In order to implement the newly revised Drug Administration Law of the People's Republic of China and the Vaccine Administration Law of the People's Republic of China, further strengthen drug supervision and management, ensure the safety of people's medication, and promote the high-quality development of the pharmaceutical industry, the Food and Drug Administration organized a study of the "Regulations on the Implementation of the Drug Administration Law of the People's Republic of China" and formed a draft revision for solicitation of comments, which is now open to the public for comments. The public can provide feedback through the following channels and methods:
2. Mailing address: Department of Policies and Regulations of the State Drug Administration (No. 1, North Luyuan, Exhibition Road, Xicheng District, Beijing), postal code 100037, and please indicate on the envelope the words "Feedback on the Implementation Regulations of the Drug Administration Law".
The deadline for comments and feedback is June 9, 2022.
Annex: Implementing Regulations of the Drug Administration Law of the People's Republic of China (Draft Amendment for Solicitation of Comments)
Implementing Regulations of the Drug Administration Law of the People's Republic of China
(Draft Amendments for Solicitation of Comments)
Chapter I General Provisions
Article 1 [Legislative Purpose] These Regulations are formulated in accordance with the Drug Administration Law of the People's Republic of China (hereinafter referred to as the Drug Administration Law) and the Vaccine Administration Law of the People's Republic of China (hereinafter referred to as the Vaccine Administration Law).
Article 2 [Basic Requirements for Drug Administration] Drug development, production, operation, use, supervision and management activities shall follow scientific requirements and ethical guidelines, comprehensively prevent and control risks, implement responsibilities, promote system construction, improve management capabilities, and ensure the safety, effectiveness and accessibility of drug use.
Article 3 [Capacity Building] The State promotes the scientific action plan for drug supervision, promotes the research and application of new regulatory tools, new standards, and new methods that are compatible with the development of the pharmaceutical industry and scientific and technological progress, and promotes the scientific and internationalization of drug supervision.
Article 4 [Government Responsibility] People's governments at all levels shall establish a drug safety coordination mechanism, strengthen drug supervision and management capacity building, study and solve major drug safety problems, improve a scientific, efficient and authoritative drug supervision system, implement drug safety management responsibilities, and promote the modernization of the drug supervision system and regulatory capacity.
The people's government at a higher level shall review and evaluate the drug supervision and management work of the people's government at the next lower level, and the local people's government at or above the county level shall review and evaluate the drug supervision and management work of the drug supervision and management department and other relevant departments, and supervise and urge the strict performance of drug safety supervision and management duties.
Article 5 [Establishment and Designation of Technical Institutions] The drug supervision and administration department under the State Council shall establish or designate national drug professional and technical institutions.
The drug supervision and management departments of the people's governments of provinces, autonomous regions and municipalities directly under the Central Government may, according to the needs of industrial development and supervision and management within their respective administrative regions, set up or designate drug professional and technical institutions.
The establishment or designation plan of local pharmaceutical professional and technical institutions shall be proposed by the drug supervision and management department of the people's government of the province, autonomous region or municipality directly under the Central Government, and reported to the people's government of the province, autonomous region or municipality directly under the Central Government for approval.
National pharmaceutical professional and technical institutions shall strengthen technical guidance for local pharmaceutical professional and technical institutions.
Article 6 [Informatization Construction] The State Council and the drug supervision and administration departments of the people's governments of provinces, autonomous regions, and municipalities directly under the Central Government shall establish a drug supervision and management information system, improve the level of informatization of online government services and supervision and law enforcement, facilitate drug administrative licensing and filing, promote the sharing of supervision and management information, and promote the improvement of the efficiency of drug supervision and management.
Chapter II: Drug Development and Registration
Section 1: Basic Requirements
Article 7 [Domestic and Foreign Research and Development Requirements] Domestic and foreign research and development activities of drugs for the purpose of listing in the territory of the People's Republic of China shall comply with the relevant requirements of laws, regulations, rules, standards and norms.
Article 8 [Establishment of a System of Technical Specifications] The drug supervision and administration department under the State Council shall, on the basis of the development of science and technology and the research and development of drugs in the mainland, and with reference to the technical requirements of internationally accepted pharmaceutical research, non-clinical research, clinical trials and other activities, organize the formulation of relevant technical specifications and guiding principles for drug development, review and verification, standards, inspection and so on.
Article 9 [Encouraging Innovation] The State improves the drug innovation system, supports basic research, applied research and original innovation of drugs, supports drug innovation oriented by clinical value, supports enterprises in adopting advanced technology and equipment to improve the level of drug safety, and provides support in scientific and technological project establishment, financing, credit, bidding and procurement, payment of prices, medical insurance and other aspects. Support enterprises to establish or jointly establish research and development institutions, encourage enterprises to cooperate with colleges and universities, scientific research institutes, medical institutions, etc. to carry out drug research and innovation, strengthen the protection of drug intellectual property rights, and improve the ability of independent drug innovation.
The State supports the inheritance and innovation of Chinese medicines, establishes a review and approval system suitable for the characteristics of Chinese medicines, and encourages the use of modern science and technology and traditional Chinese medicine research methods to carry out scientific and technological research and drug development of Chinese medicines. Promote the modernization and internationalization of Chinese medicine.
The state formulates development plans and industrial policies for the pharmaceutical industry, promotes the restructuring of the pharmaceutical industry and technological innovation, and promotes the high-quality development of the industry.
Article 10 [Accelerating The Listing Channel] The drug supervision and administration department under the State Council shall establish a system of breakthrough therapeutic drugs, conditional approval for listing, priority review and approval, and special approval, to encourage drug research and development innovation, and shorten the process of drug research and development and review. The drug supervision and administration department under the State Council shall clarify the scope, procedures, support policies and other requirements, and support the accelerated listing of qualified drugs.
Article 11[Drug Standards] Drug quality standards approved by the drug supervision and administration department under the State Council shall be drug registration standards. The drug registration standards shall comply with the relevant general technical requirements of the Pharmacopoeia of the People's Republic of China and shall not be lower than the national drug standards. Drugs shall meet the requirements of drug registration standards.
The State encourages drug marketing authorization holders to formulate drug registration standards that are higher than the national drug standards, and continues to improve drug registration standards.
Article 12 [Action Plan for Improving Standards] The State implements the Action Plan for Raising Drug Standards and establishes special funds to ensure that drug standards meet the needs of high-quality development of the industry.
After the implementation of the national drug standards, the holder of the drug marketing authorization shall evaluate and revise the drug registration standards in a timely manner.
The State encourages the conversion of drug registration standards that meet the requirements into national drug standards.
Article 13 [Reference Materials] Applicants for drug registration shall use national drug standards and reference products; if there are no national drug standards or references, the drug registration applicant shall, in accordance with regulations, submit samples, sources and related technical information of the quality standards research institute to the drug inspection institution set up or designated by the drug supervision and administration department under the State Council for its development and calibration in accordance with law.
Reference standard substances refer to substances that are used for the physical, chemical and biological tests of drugs in the national drug standards, have determined characteristics or quantitative values, and are used to calibrate equipment, evaluate measurement methods, assign or identify the values of drugs for testing.
Standard products refer to national drug reference standards that contain a single ingredient or mixed component and are used for the determination of titer, toxicity or content in biological testing, antibiotics or biochemical drugs.
Reference refers to the national drug reference material containing a single ingredient, combined component or mixed component, which is used for chemical drugs, antibiotics, partial biochemical drugs, pharmaceutical excipients, Chinese herbal medicines (including drinking tablets), extracts, proprietary Chinese medicines, biological products (physical and chemical determination) and other testing and instrument calibration.
Article 14 [Dispute Resolution Mechanism] The drug supervision and administration department under the State Council shall establish a mechanism for resolving objections to drug registration, properly handle the objections of registration applicants to the conclusions of technical review, and protect the legitimate rights and interests of applicants.
Article 15 [Standards for Excipients and Pharmaceutical Packaging Materials] The raw materials, excipients, packaging materials and containers for direct contact with drugs required for the production of drugs shall comply with the relevant general technical requirements of the Pharmacopoeia of the People's Republic of China.
Section 2: Drug Development
Article 16 [Pharmaceutical Research] Pharmaceutical research shall establish a sound quality management system, strengthen quality management, ensure that the pharmaceutical research code of conduct for drug registration, and the key research records and data are true, accurate, complete and traceable. The applicant for drug registration shall review and evaluate the institutions and personnel carrying out pharmaceutical research, and be responsible for the behavior and results of pharmaceutical research.
Article 17 [Non-clinical Research] The drug supervision and administration department under the State Council shall certify whether the research institutions for non-clinical safety evaluation of drugs comply with the quality management norms for non-clinical research of drugs; The certificate is valid for 5 years. Where it is necessary to continue to carry out non-clinical safety evaluation research activities on drugs at the expiration of the validity period, an application for renewal shall be made in accordance with the provisions of the drug supervision and administration department under the State Council between 6 months and 3 months before the expiration of the certificate.
The non-clinical safety evaluation of drugs shall be carried out in institutions that have obtained the certification certificate of quality management practices for non-clinical research of drugs.
Article 18 [Sponsor Clinical Trial Management System] The sponsor shall establish a drug clinical trial quality management system, evaluate and select the institutions and researchers to undertake clinical trials, and undertake responsibilities such as subject protection, drug quality and supply for clinical trials, trial data management, and drug safety information collection, assessment, disposal and reporting. Where the sponsor entrusts the contract research organization to undertake relevant work, it shall ensure that it has the corresponding quality assurance and quality control capabilities, and supervise its performance of its duties.
The preparation of drugs for clinical trials shall comply with the relevant requirements of the Good Manufacturing Practice for Drugs.
Drug clinical trial institutions shall have special organization and management departments, equipped with specialized personnel, and coordinate the implementation of clinical trial quality management, experimental drug management, data management, etc. Clinical trial investigators shall follow the clinical trial plan and implement clinical trials in accordance with the provisions of the Drug Clinical Trial Quality Management Practice, protect the rights and safety of subjects, and ensure that clinical trial data and records are true, accurate, complete and traceable.
Article 19: [Ethical Review Requirements] The ethics committee shall follow the relevant provisions of the competent department of health under the State Council, accept and coordinate the handling of complaints from subjects, protect the lawful rights and interests of subjects, and accept supervision and inspection by relevant departments.
To carry out multi-center drug clinical trials, an ethical review mechanism of collaborative mutual recognition can be established to ensure the consistency and timeliness of the review.
Article 20 [Change of Sponsor] During the clinical trial of a drug, if the sponsor is changed, the consent of the drug supervision and administration department under the State Council shall be obtained; if necessary, the notice of approval of the drug clinical trial shall be re-issued. The corresponding obligations and responsibilities for drug clinical trials shall be borne by the modified sponsor.
Article 21: [Research and Development of Chemical Generic Drugs] The drug supervision and administration department under the State Council shall select and publish a catalogue of reference preparations for generic drugs, and the research and development of chemical generic drugs shall select reference preparations or control drugs with reference to relevant technical guidelines.
Section 3: Drug Marketing Authorization
Article 22 [Applicant's Requirements] If the applicant for drug marketing authorization is different from the sponsor of a drug clinical trial, the applicant for the drug marketing authorization shall bear the relevant obligations and responsibilities for the marketing authorization application.
At the stage of drug registration application, the applicant and the drug trial production site shall be both in China or abroad.
Article 23 [Acceptance of Overseas Data] Clinical trial data obtained by the applicant abroad that meet the requirements of the provisions of the drug supervision and administration department under the State Council may be used to apply for drug marketing authorization. If an overseas enterprise conducts an international multi-center drug clinical trial in China and meets the relevant requirements, the clinical trial data can be used for drug marketing authorization application.
Article 24 [Drug Registration Applicants] Drug registration applicants shall establish a quality management system and have quality management capabilities, risk control capabilities and compensation capabilities related to drug development.
Article 25 [Review and Approval of Raw and Auxiliary Packages] Chemical APIs shall be reviewed and approved together with drugs in accordance with drug management; except for APIs that can be reviewed and approved separately according to the drug supervision and administration department under the State Council. If the chemical API passes the review and approval, a notice of approval of the API shall be issued.
The drug supervision and administration department under the State Council shall establish a management system for raw materials, excipients, packaging materials and containers that directly contact drugs, establish a unified registration platform, and the production enterprises of raw materials, excipients, packaging materials and containers that directly contact drugs shall register their product information and research materials.
It is forbidden to use raw materials, excipients, packaging materials and containers that are in direct contact with drugs that have been phased out by the state.
Article 26 [Conversion of Prescription Drugs and Over-the-Counter Drugs] For prescription drugs that have been approved for marketing, if the holder of the drug marketing authorization believes that it meets the conditions and requirements of the over-the-counter drug after marketing research, it may submit an application to the drug supervision and administration department under the State Council, and if it is evaluated to meet the requirements of the over-the-counter drug, it may be converted into a non-prescription drug.
If an over-the-counter drug that has been approved for marketing is found to have hidden risks after adverse reaction monitoring and post-marketing research, and is not suitable for management as an over-the-counter drug, it shall be discontinued for sale. The holder of the drug marketing authorization shall conduct full research and submit an application for prescription drugs to the drug supervision and administration department under the State Council, and if it meets the requirements after review, it may be converted into a prescription drug; if it is determined that the risk is greater than the benefit, the drug approval certificate shall be cancelled and the sold drug shall be recalled.
The drug supervision and administration department under the State Council may take the initiative to carry out assessments of prescription drugs and over-the-counter drugs, and carry out conversions in accordance with procedures.
The technical requirements for the registration, conversion and evaluation of prescription and over-the-counter drugs shall be formulated by the drug supervision and administration department under the State Council.
Article 27 [Drug Re-registration] The drug registration certificate and the notice of approval of the API issued by the drug supervision and administration department under the State Council are valid for 5 years. When the validity period expires and it is necessary to continue, the holder of the drug marketing authorization or the API manufacturer shall apply for re-registration between 12 months and 6 months before the expiration of the drug registration certificate and the API approval notice. The drug supervision and administration department shall conduct a review in accordance with the provisions; if it meets the requirements, it shall be re-registered.
Where the holder of the drug marketing authorization or the API manufacturer is an overseas enterprise, it shall submit an application for re-registration to the drug supervision and administration department under the State Council; if the drug marketing authorization holder or the API production enterprise is a domestic enterprise, it shall submit an application for re-registration to the drug supervision and management department of the people's government of the province, autonomous region or municipality directly under the Central Government where it is located.
Article 28: [Medication for Children] The State encourages the development and innovation of drugs for children, supports holders of drug marketing authorizations in developing new varieties, new dosage forms, and new specifications of drugs for children that meet the physiological characteristics of children, and gives priority to the review and approval of drugs for children. During the drug development and registration declaration period, strengthen communication with the sponsors, promote the accelerated listing of children's drugs, and meet the clinical drug needs of pediatric patients.
For the first new varieties, dosage forms and specifications approved for children, as well as increasing the indications or dosage of children, the market exclusivity period of up to 12 months is given, during which the same variety will not be approved for marketing.
Applicants are encouraged to submit R&D plans for children's dosage forms, specifications, dosages, etc. when submitting applications for marketing authorization.
Article 29: [Rare Diseases] The State encourages the development and innovation of drugs for rare diseases, supports holders of drug marketing authorizations to carry out the development of drugs for rare diseases, encourages the development of new indications for rare diseases of marketed drugs, and gives priority to the review and approval of rare disease drugs that are urgently needed clinically. During the drug development and registration declaration period, strengthen communication with the sponsors, promote the accelerated listing of rare disease drugs, and meet the clinical drug needs of rare disease patients.
For new drugs with rare diseases approved for marketing, a market exclusivity period of up to 7 years shall be given under the condition that the holder of the drug marketing authorization undertakes to ensure the supply of drugs, during which the same variety will not be approved for marketing. If the holder of the drug marketing authorization does not fulfill the commitment to guarantee supply, the market exclusivity period shall be terminated.
Section 4 Registration management of Chinese medicines
Article 30 [Definition and Management System of Chinese Medicines] "Chinese medicines" as used in the Drug Administration Law refers to medicinal substances and their preparations used under the guidance of the theory of traditional Chinese medicine, including Chinese medicinal materials, Chinese medicine drinking tablets, Chinese medicine formula granules and proprietary Chinese medicines.
The drug supervision and administration department under the State Council shall establish a full-life cycle management system that conforms to the characteristics of Chinese medicines and promote the high-quality development of Chinese medicines.
Article 31: [General Requirements for The Review of Traditional Chinese Medicines] The drug supervision and administration department under the State Council shall, in the face of the major strategic needs of the State and the needs of the people's life and health, follow the laws of the development of traditional Chinese medicines, scientifically and reasonably set up technical requirements for the evaluation of traditional Chinese medicines, and establish a review evidence system that combines the theory of traditional Chinese medicine, the experience of the use of traditional Chinese medicine, and clinical trials.
Article 32: [Protection and Utilization of Medicinal Resources] Traditional Chinese medicine resources are derived from animals, plants, and minerals, and in principle do not include substances derived from genetically modified animals and plants, as well as substances modified by chemistry and other modifications.
The State encourages the use of authentic medicinal materials and strictly restricts the use of wild animals into medicine. Where endangered wild animals and plants are involved, they shall comply with the relevant provisions of the State. The development and production of traditional Chinese medicines shall be assessed for resources to ensure the stability of the source and quality of Chinese medicinal materials, avoid adverse effects on the environment, and ensure the sustainable use of resources.
Article 33: [Implementation of Examination and Approval Management of Chinese Medicinal Materials] The State encourages the cultivation of Chinese medicinal materials and the addition of new medicinal resources.
Newly discovered substances with medicinal value and derived from animals, plants or minerals, as well as substances derived from medicinal plants introduced from abroad, for use as Chinese medicinal materials, shall be approved by the drug supervision and administration department under the State Council and included in the catalogue of Varieties of Chinese Medicinal Materials for examination and approval management.
Article 34 [Import of Medicinal Materials and Their Port Management] Medicinal materials shall be imported from ports approved by the State Council that permit the import of drugs or border ports that allow the import of medicinal materials.
The drug supervision and administration department under the State Council, together with the General Administration of Customs, will conduct an assessment of the application for additional ports allowing the import of drugs and the border ports where the import of medicinal materials is permitted. Ports where drug imports are allowed shall comply with the requirements of the national strategic regional planning.
Imported medicinal materials shall comply with the provisions of national drug standards. Where ethnic minority areas import locally used medicinal materials and medicinal materials that are not yet in the country, they shall comply with the corresponding local medicinal material standards.
After the first import of medicinal materials is examined and approved by the drug supervision and administration department under the State Council, it shall be filed with the drug supervision and management department of the place where the port is located.
The first import of medicinal materials refers to imported medicinal materials that are not from the same country or region, are not the same applicant, and are not based on the same medicinal materials.
Article 35[ Standards for Chinese Medicinal Materials] Regional folk medicinal materials that are not included in the national drug standards may be formulated by the drug supervision and management departments of the people's governments of provinces, autonomous regions, and municipalities directly under the Central Government. Local medicinal material standards shall be reported to the drug supervision and administration department under the State Council for the record. Local medicinal material standards shall be abolished after they are incorporated into the national drug standards and promulgated and implemented.
Option 1: The medicinal materials included in the local medicinal material standards should be limited to sales and use in the local area. Where it is sold and used in other provinces, autonomous regions, or municipalities directly under the Central Government, it shall be filed with the drug supervision and management department of the people's government of the province, autonomous region, or municipality directly under the Central Government where the sale is used.
Scheme 2: The medicinal materials included in the local medicinal material standards should be limited to sales and use in the local area. Where it is sold and used in other provinces, autonomous regions, or municipalities directly under the Central Government, it shall be approved by the drug supervision and management department of the people's government of the province, autonomous region, or municipality directly under the Central Government where the sale is used.
Where the raw materials of proprietary Chinese medicines involve the inclusion of medicinal materials in local medicinal material standards, they shall be handled in accordance with the relevant provisions on the registration and management of chinese medicines.
Article 36: [Administration of Examination and Approval of Chinese Medicine Drinking Tablets] The drug supervision and administration department under the State Council, together with the competent department of traditional Chinese medicine, shall include toxic Chinese medicine tablets, Traditional Chinese medicine tablets traditionally managed in accordance with preparations, Chinese medicine tablets prepared by some complex processes, and other Chinese medicine tablets that need to be examined and approved and managed into the catalogue of varieties of Chinese medicine tablets that need to be examined and approved and managed. The drug supervision and administration department under the State Council shall examine and approve the Chinese medicine tablets listed in the catalogue, and approve their quality standards and preparation procedures.
The state implements variety filing management for traditional Chinese medicine formula granules, and the production enterprise shall file a record with the drug supervision and management department of the people's government of the province, autonomous region or municipality directly under the Central Government before listing.
Article 37 [Cross-Provincial Sale of Drinking Tablets] Plan 1: Where tablets are sold and used in accordance with the norms for the preparation of traditional Chinese medicine tablets promulgated by the drug supervision and management departments of the people's governments of provinces, autonomous regions, and municipalities directly under the Central Government, they shall be filed with the drug supervision and management department of the people's government of the province, autonomous region, or municipality directly under the Central Government where the sale and use is made.
Plan 2: Tablets concocted in accordance with the norms for the preparation of traditional Chinese medicine tablets promulgated by the drug supervision and management departments of the people's governments of provinces, autonomous regions and municipalities directly under the Central Government for sale and use in other provinces, autonomous regions and municipalities directly under the Central Government shall be approved by the drug supervision and management departments of the people's governments of the provinces, autonomous regions and municipalities directly under the Central Government where the sales are used.
Section 5 Protection of Intellectual Property Rights in Pharmaceuticals
Article 38 [Patent Link] Where there is a dispute over the patent right during the application for drug registration, the parties may file a lawsuit with the people's court or apply to the patent administration department under the State Council for an administrative ruling, and the technical review of the drug shall not be suspended during the period. For chemical drugs that have passed the technical review, the drug supervision and administration department under the State Council shall make a decision on whether to approve the listing on the basis of the effective judgment, ruling or mediation document of the court or the administrative ruling of the patent administration department under the State Council; if the effective judgment, ruling, mediation document or administrative ruling has not been obtained within a certain period of time, the drug supervision and administration department under the State Council may approve the listing of the drug.
The drug supervision and administration department under the State Council shall establish a drug patent information registration platform, and the drug registration applicant and the drug marketing authorization holder shall register the relevant information of the drug patent in accordance with the regulations, and explain the relevant drug patents involved and their ownership status.
The applicant for drug registration and the holder of the drug marketing authorization shall be responsible for the authenticity, accuracy and completeness of the patent information they register.
Article 39 [Promoting the Development of Generic Drugs] The State encourages the development of generic drugs and gives market exclusivity to the first chemical generic drugs that successfully challenge patents and are the first to be approved for listing. The drug supervision and administration department under the State Council shall not approve the listing of generic drugs of the same variety within 12 months from the date of approval of the drug, except for the success of the joint challenge patent. The period of market exclusivity shall not exceed the term of the original patent right of the challenged drug.
Article 40 [Data Protection] The State shall protect the undisclosed test data and other data of some drugs approved for marketing, and no one other than the holder of the drug marketing authorization shall improperly make improper commercial use of the undisclosed test data and other data.
Within 6 years from the date on which the drug marketing authorization holder obtains the drug registration certificate, if other applicants use the data in the preceding paragraph to apply for a drug marketing license without the consent of the drug marketing authorization holder, the drug supervision and administration department under the State Council will not give permission; except for other applicants who submit the data obtained by themselves.
Except in the following circumstances, the drug supervision and administration departments shall not disclose the data provided for in the first paragraph of this article:
(1) as required by the public interest;
(b) measures have been taken to ensure that such data is not improperly commercially exploited.
Chapter III Holders of Drug Marketing Authorizations
Article 41 [General Requirements] Holders of drug marketing authorizations engaged in drug development, production, business and use activities shall establish a quality assurance system for the whole process to ensure that the whole process continues to meet the statutory requirements and continue to have the capabilities of quality management, risk prevention and control, and liability compensation.
Article 42 [Qualification Requirements for Holders] Drug marketing authorization holders shall obtain drug production licenses in accordance with the provisions of the drug supervision and administration department under the State Council, establish independent quality management departments and pharmacovigilance departments, and appoint special quality managers, quality authorized persons, and pharmacovigilance leaders in accordance with the requirements of relevant quality management norms, and perform duties such as quality management, marketing release, and pharmacovigilance.
The person in charge of quality, the quality authorized person and the person in charge of pharmacovigilance of the drug marketing authorization holder shall file a record with the drug supervision and management department of the people's government of the province, autonomous region or municipality directly under the Central Government where the drug is located in accordance with regulations. Specific administrative provisions shall be formulated by the drug supervision and administration department under the State Council.
Article 43 [Vaccine Marketing Authorization Holders] Vaccine marketing authorization holders shall establish and improve the vaccine life cycle quality management system, have the ability to manage the whole process of quality, and establish a whole chain traceability system. In addition to meeting the conditions stipulated in the Drug Administration Law and the Vaccine Administration Law, the production and supply of vaccines should also be ensured according to the needs of vaccination.
Article 44: [Appointment and Modification of Domestic Agents]
Option 1: Before the approval of the drug marketing authorization, the overseas applicant shall designate a qualified domestic enterprise legal person in China as a domestic agent, and the relevant information of the domestic agent shall be stated in the drug registration certificate.
Scheme 2: After the approval of the drug marketing authorization, the holder of the overseas marketing authorization shall designate the qualified enterprise legal person in China as the domestic agent and register with the drug supervision and management department of the people's government of the province, autonomous region or municipality directly under the Central Government. The products can only be listed for sale after the domestic agent is registered.
Domestic agents shall have the corresponding quality management capabilities and risk control capabilities, establish a quality assurance system for the whole process of drugs, and allocate corresponding management institutions and professional and technical personnel. Where there is a change in the domestic agent, it shall be registered with the drug supervision and management department of the people's government of the province, autonomous region or municipality directly under the Central Government where the agent is located in accordance with the provisions of the drug supervision and administration department under the State Council.
Article 45 [Drug Traceability Obligation] Holders of drug marketing authorizations shall establish and implement a drug traceability system, give drug traceability labels in accordance with regulations, establish an information-based traceability system, provide traceability information to drug trading enterprises and drug use units, timely and accurately record and save information on the whole process of drug production, circulation and use, realize drug traceability, and provide traceability data to drug supervision and management departments in accordance with regulations, and provide the public with drug traceability information inquiry services.
Article 46 [Pharmacovigilance Obligation] The holder of the drug marketing authorization shall establish a pharmacovigilance system, designate the person in charge of pharmacovigilance, and establish an independent pharmacovigilance department, responsible for collecting, tracking and analyzing suspected adverse reactions, establishing a risk identification, assessment and control mechanism, and ensuring the effective operation and continuous improvement of the system.
Article 47 [Holder's Management Responsibility for Entrusting Acts] Where the holder of the drug marketing authorization entrusts the production, sale, storage and transportation of drugs and pharmacovigilance work, it shall assess the quality assurance ability and risk management ability of the entrusted party, sign a entrustment agreement and quality agreement with it, and supervise the trustee to perform the obligations stipulated in the relevant agreement.
Article 48 [Risk Management Plan and Post-Marketing Research] The holder of the drug marketing authorization shall formulate a post-marketing risk management plan for the drug, take the initiative to carry out post-marketing research, and evaluate, control, communicate and review the factors affecting the safety, efficacy and quality controllability of the drug in the production, circulation and use of the drug.
Article 49 [Management of Filing and Reporting Matters] The drug supervision and administration departments of the people's governments of provinces, autonomous regions and municipalities directly under the Central Government shall strengthen the supervision of the post-marketing changes of drugs, and if it is found that the research and verification results of the filing or reporting changes that have been implemented by the holder of the drug marketing license are insufficient to prove that the changes are scientific, reasonable and controllable, they shall require the drug marketing authorization holders to make corrections and re-apply in accordance with the corrected management categories, carry out risk assessments for the drugs that have been listed and take corresponding risk control measures.
Article 50 [Post-marketing Evaluation] The holder of the drug marketing authorization shall periodically carry out post-marketing evaluation based on the post-marketing research on the safety, effectiveness and quality controllability of the drug, and conduct a comprehensive analysis and assessment of the risks and benefits of the drug. According to the post-marketing evaluation results after the assessment, measures such as revising the drug instructions, improving quality standards, improving process prescriptions, suspending production and sales, recalling drugs, and canceling drug approval documents are taken in accordance with the law.
Article 51[Transfer of Drug Marketing Authorization] The change of the holder of the drug marketing authorization shall be subject to the approval of the drug supervision and administration department under the State Council; if the same variety has different specifications, all specifications shall be changed to the holder of the same drug marketing authorization at one time.
In the process of changing the holder of the drug marketing authorization, if the production site, prescription, production process, quality standards, etc. of the drug are changed simultaneously, it shall be handled in accordance with the relevant provisions of the drug supervision department under the State Council.
Chapter IV Pharmaceutical Production
Article 52 [Production License] To engage in drug production activities, an application for a production license shall be made to the drug supervision and administration department of the people's government of the province, autonomous region or municipality directly under the Central Government where it is located, and in accordance with the provisions of the drug supervision and administration department under the State Council, submit the information that meets the conditions provided for in Article 42 of the Drug Administration Law. The drug supervision and administration departments of the people's governments of provinces, autonomous regions and municipalities directly under the Central Government shall make a decision within 30 working days from the date of acceptance of the application.
The drug supervision and management departments of the people's governments of provinces, autonomous regions, and municipalities directly under the Central Government shall organize technical examinations, assessments, and on-site inspections, and grant licenses and issue drug production licenses to those that meet the prescribed conditions; The time required for technical review and assessment, on-site inspection, enterprise rectification, etc. is not counted in the time limit.
Where new vaccine production enterprises are established, the competent departments for industry and informatization of the people's governments of provinces, autonomous regions and municipalities directly under the Central Government shall conduct a review in accordance with the national vaccine industry development plan and industrial policy. After review and approval, apply for a drug production license in accordance with the regulations.
Article 53:[Matters Specified in Production Licenses] The matters specified in drug production licenses are divided into licensing matters and registration matters. Where a pharmaceutical production enterprise changes its production address, scope of production, and other licensing matters, it shall submit an application to the original licensing authority 30 days before the change; the original licensing authority shall make a decision within 15 working days from the date of receipt of the application. The licensing may not be changed without approval.
Article 54[Production License Period] The validity period of a drug production license is 5 years. Where it is necessary to continue to produce drugs at the expiration of the validity period, an application for a new drug production license shall be issued in accordance with the provisions of the drug supervision and administration department under the State Council between 6 months and 2 months before the expiration of the license.
Article 55 [Personnel Management Requirements] Holders of drug marketing authorizations and drug production enterprises shall, in accordance with the provisions of the Drug Administration Law, the Vaccine Administration Law, and the good manufacturing practices for drugs, appoint personnel in key positions such as enterprise leaders, production management leaders, quality management leaders, and quality authorized persons.
Key personnel such as the person in charge of the enterprise, the person in charge of production, the person in charge of quality and the person authorized by quality shall be the full-time personnel of the enterprise.
The quality authorized person is mainly responsible for the release of drugs to ensure that the production and inspection of each batch of released products comply with relevant laws and regulations and drug registration management requirements. The quality authorized person independently performs his duties and shall not be released without the signature and consent of the quality authorized person.
Article 56 [Production Management Requirements] Engaged in drug production activities, a quality management system covering the entire process of drug production shall be established to ensure that drug production activities continue to comply with the good manufacturing practices for drugs and relevant laws and regulations.
Data and records such as drug production and inspection shall be true, complete and traceable.
Article 57 [Material Management Requirements] Engaged in drug production activities, supplier reviews shall be conducted on raw materials, excipients, packaging materials and containers that directly contact drugs, etc., and specific operating procedures shall be established to ensure that the raw materials, excipients, packaging materials and containers directly in contact with drugs purchased and used meet the requirements for medicinal use, and comply with the quality management norms formulated by the drug supervision and administration department under the State Council and the relevant requirements such as related review and approval.
Article 58 [Management of Entrusted Production by Holders] Where the production of drugs is entrusted, the holder of the drug marketing authorization shall perform the obligations of supplier review of raw and auxiliary materials, annual report on products, review of change management and release of products on the market, supervise the trustee in performing the obligations stipulated in the agreement, and ensure that the production process continues to meet the statutory requirements.
The trustee shall organize production in accordance with the Good Manufacturing Practice for Drugs and strictly implement the quality agreement. The entrusted party shall not entrust production again.
Article 59[Overseas Production Requirements] Where drug production sites are overseas, their production activities shall comply with the relevant requirements of laws, regulations, rules, standards and norms.
Article 60 [Listed And Sold of Large-scale Batches of Drugs Before Registration] Where the quality standards and production processes are consistent with the registration certificate, and the production process of a batch of drugs of commercial scale meets the requirements for drug production quality management, after obtaining the drug registration certificate, it may be listed for sale; the holder of the drug marketing license shall strengthen the management and risk management of production and sales.
Article 61:[Vaccine Entrusted Production] In any of the following circumstances, where the existing production capacity of the vaccine marketing license holder cannot meet the demand, upon approval by the drug supervision and administration department under the State Council, it may entrust a vaccine production enterprise with the conditions to produce:
(1) where the competent department of industry and information technology under the State Council submits a reserve need;
(2) Where the competent department of health under the State Council proposes that disease prevention and control is urgently needed;
(3) Multivalent vaccines that really need to be commissioned for production.
Vaccine production enterprises that accept entrustment shall comply with the Drug Administration Law, the Vaccine Administration Law and the relevant provisions of the state to ensure the quality of vaccines.
Article 62 [Vaccine Production Requirements] The holder of the vaccine marketing license shall use information technology to truthfully record all data formed in the process of production and inspection to ensure that the whole process of production continues to meet the statutory requirements. For manual operation steps that cannot be used to collect data online, the data formed by the process should be entered into the relevant information system or converted into electronic data in a timely manner to ensure that the relevant data is true, complete and traceable.
Article 63[Management of Chinese Medicinal Materials] Chinese medicinal materials used in the production of drugs shall comply with the national drug standards or the local medicinal materials standards formulated by the drug supervision and management departments of the people's governments of provinces, autonomous regions and municipalities directly under the Central Government in accordance with law.
The State encourages the development of standardized planting and breeding of Chinese medicinal materials, orderly promotes the implementation of quality management norms for the production of Chinese medicinal materials, and gradually realizes the standardized and intensive development of key Chinese medicinal materials varieties.
Manufacturers of Traditional Chinese medicine tablets and holders of marketing authorizations for proprietary Chinese medicines shall strictly implement the responsibility of supplier review, strengthen the authenticity identification, inspection and acceptance of purchased Chinese herbal medicines, and ensure the quality of purchased Chinese medicinal materials.
Article 64:[Processing of Origin of Chinese Medicinal Materials] The processing of Chinese medicinal materials at the place of origin shall not adversely affect the quality of Chinese medicinal materials. The drug supervision and management departments of the people's governments of provinces, autonomous regions and municipalities directly under the Central Government shall formulate management requirements and technical guidelines for the processing of Chinese medicinal materials on the basis of the distribution of local Chinese medicinal material resources, natural environmental conditions, traditional planting and breeding history, and the characteristics of authentic medicinal materials.
Article 65:[Packaging Labels for Chinese Medicinal Materials] Chinese medicinal materials used in the production of pharmaceuticals shall have packaging labels. The content of the label shall include the product name, the source of the medicinal materials, the place of origin (marked to the county-level administrative region), the date of harvest, the date of packaging, the implementation standard, the shelf life, the storage conditions, the supplier unit, etc., and shall be accompanied by a quality qualification mark.
Article 66:[Production and Management of Chinese Medicine Tablets] Chinese medicine tablet production enterprises shall establish a quality management, risk prevention and control and traceability system for Chinese medicine tablets, and implement whole-process management of activities such as the preparation and sale of Chinese medicine tablets.
Chinese medicine tablet production enterprises shall not entrust production, and shall not purchase Chinese medicine tablets in separate packaging or change packaging and sell them.
Article 67:[Packaging Labels for Chinese Medicine Tablets] Chinese medicine tablets shall have standardized packaging and labeling, and packaging materials that directly contact Chinese medicine tablets shall comply with medicinal requirements. The contents of the label of Chinese medicine tablets include the product name, the source of the medicinal materials, the specifications, the origin of the medicinal materials (marked to the county-level administrative region), the production enterprise, the product batch number, the production date, the shelf life, the implementation standards, the storage conditions, etc., and the quality qualification mark is attached.
Article 68:[Management of Chinese Medicine Formula Granules] Chinese medicine formula granule production enterprises shall have complete production capacity for the preparation, extraction, concentration, drying, granulation, etc. of Chinese medicine drinking tablets, and prepare Chinese medicine drinking tablets for the production of Chinese medicine formula granules on their own.
Traditional Chinese medicine formula granule production enterprises shall perform the main responsibility and related obligations of the whole life cycle of the drug, implement the management of the whole production process, follow the relevant requirements of the Good Manufacturing Practice of Drugs, establish a traceability system, and have the ability to manage risks.
Article 69:[Segmented Production Management] Innovative drugs with special requirements for production processes, facilities and equipment, or drugs that are urgently needed clinically, may be produced in stages upon approval by the drug supervision and administration department under the State Council.
Where the drug production process involves multiple production addresses, the drug marketing authorization holder shall establish a unified quality assurance system covering the entire process of drug production and all production addresses to ensure that the drug production process continues to meet the statutory requirements.
Chapter V: Drug Business
Article 70:[Business License] To engage in drug wholesale activities, an application for a business license shall be made to the drug supervision and administration department of the people's government of the province, autonomous region, or municipality directly under the Central Government where it is located, and in accordance with the provisions of the drug supervision and administration department under the State Council, submit materials that meet the requirements provided for in Article 52 of the Drug Administration Law. The drug supervision and administration departments of the people's governments of provinces, autonomous regions and municipalities directly under the Central Government shall make a decision within 20 working days from the date of acceptance of the application.
To engage in drug retail activities, it shall apply for a business license from the drug supervision and management department of the people's government at the districted municipal level or the drug supervision and administration department of the people's government at the county level where it is located, and submit the materials that meet the conditions provided for in Article 52 of the Drug Administration Law in accordance with the provisions of the drug supervision and administration department under the State Council. The drug supervision and administration department shall make a decision within 20 working days from the date of accepting the application.
The drug supervision and administration department that accepts the application organizes technical review and on-site inspection, and grants a license and issues a drug business license to those that meet the prescribed conditions; for those that do not meet the prescribed conditions, it will not be licensed and the reasons shall be explained in writing. The time required for technical review, on-site inspection, enterprise rectification, etc. is not counted in the time limit.
The headquarters of an enterprise engaged in pharmaceutical retail chain business activities shall obtain a drug business license in accordance with the provisions of the first paragraph of this Article.
Article 71:[Changes in Matters Specified in Business Licenses] The matters specified in drug business licenses are divided into licensing matters and registration matters.
Where a pharmaceutical trading enterprise changes its business mode, business address, drug business scope, warehouse address, quality responsible person, and other licensing matters, it shall submit an application to the original licensing authority 30 days before the change; the original licensing organ shall make a decision within 15 working days from the date of accepting the application for change. The licensing may not be changed without approval.
Where there is a change in the registration matters such as the enterprise name, unified social credit code, legal representative, and principal responsible person specified in the drug business license, the registration of the change of the drug business license shall be handled with the licensing organ within 30 days of the change. The issuing authority shall complete the registration of the change within 10 working days.
Article 72 [Validity Period of Drug Business License] Where a drug business license is valid for 5 years and it is necessary to continue to trade drugs, it shall apply for a re-issuance of a drug business license in accordance with the provisions of the drug supervision and administration department under the State Council between 6 months and 2 months before the expiration of the license. Except in the circumstances provided for in the second paragraph of this article, the drug supervision and administration department shall make a decision on whether to reissue the drug business license before the expiration of the validity period of the drug business license.
In any of the following circumstances, a drug business license shall not be re-issued:
(1) Failing to submit an application for re-issuance within the prescribed time limit;
(2) Where a pharmaceutical trading enterprise has been suspended for more than 1 year.
Article 73:[Reduction of Drug Business Scope] Pharmaceutical trading enterprises shall have business premises and warehouses appropriate to their business scope and scale of operation, and store or sell drugs in places approved by the drug supervision and management departments in accordance with the business methods and business scope specified in the drug business license.
Where a pharmaceutical trading enterprise does not have the operating conditions and capabilities of some varieties of drugs within the scope of the licensed business, it shall take the initiative to report to the local drug supervision and management department and suspend the business activities of the corresponding varieties. After the enterprise re-meets the corresponding conditions, it shall meet the requirements after the local drug supervision and management department meets the requirements on the spot before it can re-operate the corresponding varieties of drugs.
Where a pharmaceutical trading enterprise still fails to meet the corresponding conditions and capabilities after rectification, it shall reduce the scope of drug business corresponding to the drug business license.
Article 74:[Drug Traceability Requirements] Drug trading enterprises shall establish and implement a drug traceability system, request and check drug traceability information in accordance with regulations, and timely and accurately record, save and upload drug traceability data through informationization and other means.
Article 75:[Classification Management of Prescription Drugs and Non-prescription Drugs] The State implements a classified management system for prescription drugs and non-prescription drugs. According to the safety of over-the-counter drugs, the state divides over-the-counter drugs into Class A over-the-counter drugs and Class B over-the-counter drugs.
Pharmacists who have been qualified in accordance with the law as provided for in Article 52 of the Drug Administration Law refer to practicing pharmacists. Pharmaceutical retail enterprises dealing in prescription drugs and Class A non-prescription drugs shall be equipped with practicing pharmacists who match the number of prescription reviews and the ability of pharmaceutical services. Pharmaceutical retail enterprises that only deal in Class B over-the-counter drugs may appoint other pharmaceutical technicians in accordance with regulations.
Licensed pharmacists or other pharmaceutical technicians are responsible for the company's drug quality management, prescription review and supervision and allocation, rational drug use guidance and consulting services, and adverse drug reaction information collection and reporting.
Article 76:[Sale of Prescription Drugs] Pharmaceutical retail enterprises shall, in accordance with regulations, sell prescription drugs on the basis of prescriptions, and prescription drugs shall be placed on closed shelves, and must not be sold on shelves, and must not give or promote prescription drugs or Class A non-prescription drugs to the public by buying drugs for gifts or buying commodity gift drugs. Where drugs with special management requirements are sold, they shall also be registered under their real names, and the number of people shall be limited.
Article 77 [Drug Retail Chain Operation] The headquarters of an enterprise engaged in pharmaceutical retail chain business activities shall set up a special quality management organization and full-time personnel to establish a unified quality management system for the stores to which they belong, so as to realize the unified identification of enterprises, a unified management system, a unified computer system, a unified procurement and distribution, a unified bill management, and a unified standard and specification of pharmaceutical services, to ensure that the stores to which they belong continue to meet the statutory requirements.
The headquarters of the drug retail chain shall not sell drugs to the outside world, and the drug retail chain stores shall not purchase drugs from units other than the headquarters of the drug retail chain to which they belong.
Article 78 [Transportation and Distribution] Engaged in the transportation and distribution of drugs, they shall formulate a quality management system in accordance with the provisions of the drug supervision and management departments, strictly implement the operating procedures, and take effective measures in accordance with the requirements of drug packaging, quality characteristics, temperature control, etc., to ensure the quality and safety of drugs in the process of transportation and distribution. The retail distribution of drugs shall have independent special labels and sealed labels.
Plan 1: Where the distribution of drugs is entrusted, the drug trading enterprise shall assess the quality assurance ability and risk management ability of the entrusted party, sign a commission agreement and quality agreement with it, supervise the trustee in performing the obligations stipulated in the relevant agreement, and file a record with the drug supervision and management department of the people's government of the province, autonomous region or municipality directly under the Central Government where it is located. Where the cold chain distribution of drugs is entrusted, it shall be ensured that the entrusted party is equipped with corresponding refrigeration and freezing facilities and equipment, and that the cold chain drugs are in a specified temperature environment during the whole process of transportation, and the temperature is regularly monitored and recorded.
Scheme 2: Those engaged in the distribution of cold chain drugs shall be equipped with refrigeration and refrigeration facilities and equipment as required, and shall be filed with the drug supervision and management department of the people's government of the province, autonomous region or municipality directly under the Central Government where they are located. Cold chain drugs should be in a specified temperature environment during the whole process of transportation. Cold chain storage and transportation shall meet the requirements, and regularly monitor and record the temperature.
Scheme 3: Those engaged in the entrusted distribution of drugs shall report to the drug supervision and management department of the people's government of the province, autonomous region or municipality directly under the Central Government where they are located. Those engaged in the entrusted distribution of drugs in the cold chain shall be equipped with refrigeration and refrigeration facilities and equipment as required, and the cold chain drugs shall be in the prescribed temperature environment during the whole process of transportation, and the temperature shall be monitored and recorded regularly.
Article 79:[Vaccine Entrusted Distribution] Holders of drug marketing authorizations may entrust enterprises with the transportation and storage conditions for refrigerated and frozen drugs stipulated in the quality management of drug business to distribute and store vaccines regionally. The holder shall assess the distribution capacity of the vaccine distribution enterprises, strictly control the number of distribution enterprises, and ensure that the distribution process continues to meet the statutory requirements.
The holder of the drug marketing authorization shall promptly report to the drug supervision and management department of the people's government of the province, autonomous region or municipality directly under the Central Government where the vaccine is received and the assessment of the information entrusted for distribution, the distribution conditions of the transportation unit, the distribution capacity and the information traceability ability of the entrusted distribution vaccine. Where the disease prevention and control institution entrusts the distribution enterprise to distribute vaccines, it shall report to the drug supervision and management department at the same level and the competent department of health and health.
Article 80:[Requirements for The Sale of Special Drugs] Narcotic drugs, psychotropic substances, toxic drugs for medical use, and radioactive drugs shall be stored in special warehouses or counters during operation and use, and specially managed by special personnel, and it is strictly forbidden to mix them with other drugs. The establishment of narcotic drugs and psychotropic substances in other places shall be subject to the approval of the drug supervision and management department under the State Council.
Article 81:[Management of Sales Entrusted by Holders] Where a drug marketing authorization holder entrusts the sale of drugs, and the drug marketing authorization holder or drug trading enterprise entrusts the storage and transportation of drugs, it shall be filed with the drug supervision and management department of the people's government of the province, autonomous region, or municipality directly under the Central Government where the child is located after obtaining the consent of the drug supervision and management department of the people's government of the province, autonomous region, or municipality directly under the Central Government where the drug is located.
Enterprises that accept entrusted storage shall carry out storage activities in accordance with the requirements of the drug business quality management standards, perform the obligations of the entrustment agreement, and bear corresponding legal responsibilities. Enterprises that accept entrusted storage shall not entrust the storage of drugs again.
Article 82:[Drug Network Sales Management] The main body engaged in drug network sales activities shall be the holder of the drug marketing license established in accordance with law or the drug trading enterprise, and the drugs sold shall be the varieties held by the drug marketing license holder or the varieties licensed by the drug trading enterprises.
Engaging in drug network sales activities shall comply with the requirements of the drug business quality management standards, and the relevant records of drug sales, storage, distribution, quality control and so on shall be complete and accurate, and shall not be fabricated or tampered with.
Article 83:[Third-Party Platform Management Obligations] Third-party platform providers for drug network transactions shall file a record with the drug supervision and management department of the people's government of the province, autonomous region, or municipality directly under the Central Government where they are located, and must not provide services related to drug network sales without filing.
Third-party platform providers shall establish a drug network sales quality management system, set up specialized agencies, and allocate relevant professional personnel such as pharmaceutical technicians, and establish and implement drug quality management, distribution management and other systems. Third-party platform providers must not directly participate in drug network sales activities.
The third-party platform provider shall review the qualifications of the drug marketing authorization holders and drug trading enterprises, inspect the released drug information, manage the transaction behavior, and save the drug display and transaction management information. Where problems in drug trading are discovered, they shall be promptly and proactively stopped, and where major problems involving drug quality and safety are involved, they shall be promptly reported to the drug supervision and management departments.
Article 84:[Online Retail Management of Drugs] Where pharmaceutical retail enterprises sell prescription drugs through the Internet, they shall ensure that the source of the prescription is true and reliable, and can only be allocated after review. For those who have not passed the prescription review, the packaging, labeling, instructions and other information of the prescription drug shall not be displayed directly.
Drugs with special management by the State and high drug use risks shall not be retailed through the Internet, and the specific catalogue shall be formulated by the drug supervision and administration department under the State Council.
Article 85:[Emergency Management Requirements] When there is a public health emergency or other emergency that seriously threatens public health, pharmaceutical retail enterprises shall strictly abide by the emergency response regulations of the people's governments at all levels, and take measures such as removing goods from shelves and suspending sales as required.
Article 86:[Prohibitive Provisions] Holders of drug marketing authorizations and drug trading enterprises are prohibited from engaging in the following acts:
(1) Purchasing, storing, transporting, or selling drugs without lawful origin;
(2) Providing conditions such as drugs, qualification certification documents, bills, or places for others' illegal business operations;
(3) Changing the scope of business, mode of operation, business address, or storage address without authorization;
(4) Operating drugs in other ways such as exhibitions, expositions, trade fairs, ordering fairs, and promotion meetings outside the production and business premises.
Article 87:[Individuals Carrying a Small Amount for Self-Use] Where an individual carries or sends a small amount of drugs for personal use into the country, he shall declare it in accordance with the provisions of the Customs Administration, and the drugs shall not be sold or disguised in the territory after they enter the country.
Chapter VI Pharmaceutical Affairs Management of Medical Institutions
Article 88:[Division of Duties] Drug supervision and management departments and competent health departments shall, on the basis of their respective duties, supervise and manage the quality of drugs and the use of drugs in the use links.
Article 89 [Drug Quality Management System and Requirements of Medical Institutions] Medical institutions shall establish and improve the drug quality management system, improve the quality management system for the purchase, acceptance, storage, maintenance and use of drugs, clarify the post responsibilities of the staff in each link, and set up special departments or designate special personnel to be responsible for drug quality management.
Article 90: [Medical Institutions Purchase Drugs] Medical establishments shall purchase drugs from drug marketing authorization holders, traditional Chinese medicine tablet production enterprises, and drug wholesale enterprises.
Public medical institutions shall, in accordance with regulations, purchase drugs through centralized pharmaceutical procurement platforms.
Medical institutions shall establish and implement a system for inspecting and accepting the incoming goods of drugs, and shall accept the purchased drugs one by one, and establish true and complete records. The drug purchase inspection and acceptance record shall indicate the generic name of the drug, the holder of the drug marketing authorization (the Chinese medicine tablet indicates the production enterprise and place of origin), the approval document number, specification, batch number, dosage form, the validity period (the Chinese medicine tablet indicates the shelf life), the supply unit, the quantity of arrival, the purchase price, the date of arrival, the acceptance result, and other matters stipulated by the drug supervision and administration department under the State Council.
Medical establishments accepting donated drugs or urgently invoking drugs shall implement the provisions of the preceding paragraph.
Article 91: [Storage and Maintenance of Medical Institutions] Medical institutions shall establish and implement a drug maintenance management system, and adopt necessary measures such as temperature control, moisture prevention, light avoidance, ventilation, fire prevention, insect prevention, rat prevention, and pollution prevention to ensure the quality of drugs.
Medical institutions shall be equipped with drug maintenance personnel, regularly inspect and maintain stored drugs, monitor and record the temperature and humidity of the storage area, maintain storage facilities and equipment, and establish corresponding maintenance files.
Article 92 [Retrospective Management of Medical Institutions] Medical institutions shall establish and implement a drug traceability management system, and when purchasing drugs, they shall obtain and check the traceability information of the purchased drugs from the supplier unit, record the drug use activities, the records shall be true, accurate, complete and traceable, and provide traceability information to the competent health departments and drug supervision and management departments as required.
Article 93: [Pharmacovigilance in Medical Establishments] Medical establishments shall establish and implement a pharmacovigilance system, improve the level of safe and rational use of drugs, discover adverse drug reactions and other harmful reactions related to medication, and shall report to the local health department and the drug supervision and management department at the same time in accordance with relevant provisions, communicate with drug marketing authorization holders and patients on risks, and timely and effectively control drug use risks.
When medical institutions discover cluster events of adverse drug reactions, they shall actively treat patients, quickly carry out clinical investigations, analyze the causes of the incident, and when necessary, take emergency measures such as suspending drug use.
Article 94:[Requirements for Handling Drug Quality Problems in Medical Institutions] Where medical institutions discover that there are quality problems or other potential safety hazards in the drugs purchased or used, they shall immediately stop using them, carry out risk investigation and control, give feedback to the supplier unit, and promptly report to the local drug supervision and management department.
Medical institutions shall actively assist drug marketing authorization holders and Chinese medicine tablet manufacturers to perform drug recall obligations.
Article 95: [Rational Use of Drugs] Medical establishments shall be patient-centered, clinically demanding, and follow the principles of safe, effective, economical and reasonable use of drugs.
Medical institutions shall strengthen the management of prescription issuance, review and deployment, improve the level of rational drug use by physicians, and strengthen the role of pharmacists and other pharmaceutical technicians in the management of rational drug use.
Pharmacists and other pharmaceutical technicians shall perform duties such as drug quality management, prescription and review of medication orders, drug dispensing, rational medication guidance and education, drug treatment management, and pharmaceutical information services, and promote rational drug use.
Article 96:[Provisions on the Administration of Pharmaceutical Affairs in Internet Hospitals] Internet hospitals carrying out Internet diagnosis and treatment activities shall strictly abide by the management provisions of the competent departments of health and health. Where adverse medical quality events and suspected adverse reactions occur, they shall be reported in accordance with relevant national provisions.
Article 97: [Prescription Issuance] Physicians shall, in accordance with the needs of patients' disease prevention, treatment, and diagnosis, follow the guidelines for the clinical application of drugs, clinical diagnosis and treatment guidelines, drug instructions, and other rational use of drugs, and issue prescriptions in accordance with laws, regulations, diagnosis and treatment norms.
The issuance of electronic prescriptions shall comply with the relevant provisions of the competent departments of health.
Article 98: [Review and Allocation of Prescriptions] Pharmacists of medical establishments who review and dispense prescriptions shall be pharmacists or other pharmaceutical technicians who have been qualified in accordance with law.
When allocating prescriptions for toxic drugs for medical use, they shall be signed and confirmed by the formulators and review personnel with the technical title of pharmacist or above.
Personnel reviewing, allocating, and checking electronic prescriptions shall employ electronic signatures or traces left by information systems to ensure that information can be traced.
Article 99: [Opening of Prescriptions] Medical establishments shall provide patients with prescriptions that meet the requirements of the competent department of health under the State Council, and patients may purchase drugs outside the prescription.
Article 100 [Compassionate Use] For drugs that are currently undergoing clinical trials for the treatment of diseases that are seriously life-threatening and there is no effective means of treatment, and the physician believes that the benefits may outweigh the risks based on the medical analysis of the patient's condition and the patient cannot participate in the clinical trial of the drug, he may make a suggestion for the patient to sympathetically use the experimental drug.
Compassionate use of experimental drugs should follow the principles of voluntary requirements of patients, medical ethics and informed consent, and after review and approval by the ethics committee, they may be used by physicians with experience in the use of experimental drugs or training experience in institutions that conduct clinical trials for patients with the same condition as the subjects.
Article 101: [Emergency Use of Drugs] When there is a particularly major public health emergency or other emergency that seriously threatens public health, and there is no effective means of treatment, the competent department of health under the State Council shall, on the basis of the needs of medical treatment, put forward a recommendation for emergency use, and the drug supervision and administration department under the State Council shall organize demonstrations, and after the consent of the State Council, may urgently use drugs that are undergoing clinical trials within a certain scope and period of time, or use the use of drugs not specified in the drug instructions to carry out treatment.
Article 102:[Application for Preparation Licenses for Medical Institutions] Medical institutions establishing preparation rooms shall submit an application to the drug supervision and management department of the people's government of the province, autonomous region, or municipality directly under the Central Government where they are located, and the drug supervision and management department of the people's government of the province, autonomous region, or municipality directly under the Central Government shall make a decision within 30 working days from the date of receipt of the application. Where approval is granted, a preparation license shall be issued to a medical institution.
Article 103:[Preparation and Commissioned Preparation of Medical Institutions] Medical establishments shall prepare their own preparations for medical institutions. Where it is truly necessary to entrust, upon approval by the drug supervision and management department of the people's government of the province, autonomous region or municipality directly under the Central Government, it may entrust other medical institutions in that province, autonomous region or municipality directly under the Central Government that have obtained a medical institution preparation license or a pharmaceutical production enterprise with the corresponding production scope to formulate it. Specific provisions shall be formulated by the drug supervision and administration department under the State Council.
Article 104: [Modification of Medical Institution Preparation Licenses] Where medical establishments add new medical institution preparation preparation types, change the preparation site, or other licensing matters, they shall apply to the original approving organ for a change in the medical institution's preparation license 30 days before the change in the licensing matters; without approval, the licensing matters must not be changed. The original approving authority shall make a decision within 15 working days from the date of receipt of the application. The time required for technical review and assessment, on-site inspection, rectification of medical institutions, etc. is not counted in the time limit.
Article 105:[Renewal of Medical Institution Preparation License] The validity period of a medical institution preparation license is 5 years. At the expiration of the validity period and it is necessary to continue to prepare preparations, the medical institution shall apply for the renewal of the preparation license of the medical institution in accordance with the provisions of the drug supervision and administration department under the State Council between 6 months and 2 months before the expiration of the license.
Where a medical establishment terminates the preparation or closes down, it shall apply to the original licensing authority to reduce the scope of the corresponding preparation or cancel the medical institution's preparation license.
Article 106: [Registration and Filing of Preparations of Medical Institutions] Preparations of medical institutions shall be varieties that are clinically needed by the medical institution and are not available on the market.
The State encourages the transformation of preparations from medical institutions into new drugs.
Medical institutions formulating preparations shall submit relevant materials and samples in accordance with the provisions of the drug supervision and administration department under the State Council, and only after approval by the drug supervision and management department of the people's government of the province, autonomous region or municipality directly under the Central Government where they are located and the preparation approval number is issued, they can be formulated. However, only varieties of traditional Chinese medicine preparations prepared by traditional processes can be formulated by medical institutions after filing with the drug supervision and management department of the people's government of the province, autonomous region or municipality directly under the Central Government in accordance with the provisions of the drug supervision and administration department under the State Council.
The validity period of the approval number of the preparation of the medical institution is 3 years. Where it is necessary to continue to formulate at the expiration of the validity period, it shall apply for re-registration with the drug supervision and administration department of the people's government of the province, autonomous region or municipality directly under the Central Government in accordance with the provisions of the drug supervision and administration department under the State Council.
Article 107: [Prohibited Varieties] Varieties containing active ingredients that have not been approved by the drug supervision and administration department under the State Council, chemical drug preparations that have been approved for use with active ingredients for unapproved indications, biological products other than allergens, chinese medicine injections, compound preparations composed of traditional Chinese medicines and chemical drugs, and toxic drugs for medical use, etc., must not be used as preparations of medical institutions.
Article 108: [Specifications for the Quality Management of Preparation Preparations of Medical Institutions] Medical institutions formulating preparations shall comply with the quality management norms for the preparation of preparations of medical institutions formulated by the drug supervision and administration department under the State Council, establish and improve the quality management system for the preparation of preparations of medical institutions, and ensure that the whole process of preparation preparation continues to meet the statutory requirements.
The legal representative and main person in charge of the medical institution are fully responsible for the preparation of the preparation of the medical institution.
Article 109: [Preparation and Use of Chinese Medicine Tablets] For Chinese medicine tablets that are not available on the market, medical institutions may concoct and use them in their medical institutions according to the needs of the prescription of the doctors of the medical institutions. Medical institutions shall abide by the relevant provisions on the preparation of Chinese medicine tablets, be responsible for the quality of the Chinese medicine tablets they concoct, and ensure the safety of drugs. Medical institutions preparing Chinese medicine tablets shall file a record with the drug supervision and management department of the people's government at the districted municipal level where they are located.
Article 110:[Sales and Adjustment of Preparations of Medical Institutions] Preparations of medical institutions may only be used in this medical establishment on the basis of a doctor's prescription, and must not be sold on the market or sold in disguise, and advertisements for preparations of medical institutions must not be published.
In the event of a disaster, epidemic situation, emergency or urgent clinical need and the market is not supplied, with the approval of the drug supervision and management department of the people's government of the province, autonomous region or municipality directly under the Central Government, the preparation of medical institutions may be transferred and used between the designated medical institutions in the province, autonomous region or municipality directly under the Central Government within the prescribed period of time. The transfer and use of special preparations prescribed by the drug supervision and administration department under the State Council and the transfer and use of preparations from medical institutions between provinces, autonomous regions and municipalities directly under the Central Government shall be subject to the approval of the drug supervision and administration department under the State Council.
Article 111: [Requirements of Other User Units] Units using drugs other than medical institutions shall comply with the "Drug Administration Law" and the provisions of these Regulations on the use of drugs by medical institutions.
Drug use units refer to institutions that use drugs to provide medical and other technical services to others, including medical institutions, disease prevention and control institutions, blood banks, single plasma collection stations and other units.
Chapter VII: Guarantee of Drug Supply
Article 112:[Ensuring Access to Drugs] The State promotes the balanced development of new drugs and generic drugs whose quality efficacy is consistent with the original drugs and can be clinically replaced, so as to improve the accessibility of drugs.
Article 113: [State Reserves] The State shall establish a drug reserve system at the central and local levels. In accordance with the needs of public health emergency response and treatment, the competent department of industry and information technology under the State Council, together with relevant departments, strengthens the reserve of materials, technology and production capacity, and establishes a dynamic adjustment mechanism.
The State shall establish a central reserve system for raw materials for narcotic drugs. The drug supervision and administration department under the State Council shall, in accordance with the medical needs of narcotic drugs, strengthen the reserve of raw materials and production capacity of narcotic drugs in response to major emergencies such as natural disasters, and establish a dynamic adjustment mechanism.
Article 114:[Transfer of Transfers] In the event of a major disaster, epidemic situation, or other emergency, the State Council has the right to make an emergency call to reserve drugs nationwide, and local people's governments at or above the county level have the right to urgently transfer reserve drugs within their respective administrative regions, in accordance with the needs of public health emergencies and treatment.
In the event of disasters, epidemics and other emergencies, the competent departments for industry and informatization under the State Council, the competent departments for health and health under the State Council, and other departments may urgently allocate drugs from pharmaceutical production and trading enterprises or medical institutions nationwide as needed.
Article 115: [Administration of Essential Drugs] The competent department of health under the State Council, together with the medical security and drug supervision and administration departments under the State Council, shall formulate a national essential drug catalogue on the basis of the basic drug needs for disease diagnosis and treatment, and periodically assess and dynamically adjust it, and the adjustment period shall not exceed 3 years in principle. Drugs that are newly approved and marketed, whose efficacy has significantly improved compared with those already listed, and whose prices are reasonable, can be included in a timely manner. Encourage medical institutions to prioritize the procurement and use of essential medicines.
Article 116: [Mechanism for Guaranteeing the Supply of Drugs in Shortage] The competent department of health under the State Council, together with relevant departments, shall establish a coordinated monitoring mechanism and information reporting system for drugs in shortage, summarize and analyze and demonstrate the monitoring information, determine the list of drugs in shortage, and make dynamic adjustments. The competent department of industry and information technology under the State Council shall coordinate the production, supply and distribution of drugs in short supply together with the drug supervision and administration department under the State Council, the competent department of health and health, the financial department and other departments.
Drug marketing authorization holders and drug use units shall take the initiative to collect and record the shortage of drugs and promptly report to the competent health departments of people's governments at the county level or above. Where the holder of the drug marketing authorization stops producing drugs in short supply, he shall report to the drug supervision and management department under the State Council or the drug supervision and management department of the people's government of the province, autonomous region or municipality directly under the Central Government in accordance with regulations, and the drug supervision and management department shall promptly notify the competent department of industry and informatization at the same level, the competent department of health and health, the department of medical security and other departments.
Article 117:[Measures to Guarantee the Supply of Drugs in Shortage] The State shall establish a system for guaranteeing the supply of drugs in short supply and establish a fund for guaranteeing the supply of drugs in short supply.
The State shall establish and improve the national shortage of drug monitoring and early warning system, and collect information on drug research and development, production, circulation, and use. Holders of drug marketing authorizations, drug manufacturers, drug distribution enterprises and medical institutions shall submit relevant information in accordance with regulations.
The state responds to and disposes of drugs in shortage according to the cause of the shortage in grades and classifications. Encourage the development and production of drugs in short supply, and give priority to the review and approval of drugs in urgent clinical need, new drugs for the prevention and treatment of major infectious diseases and rare diseases.
Article 118:[Designated Production] The State implements designated production of drugs in short supply to ensure the stable production and effective supply of drugs in short supply. The competent department of industry and information technology under the State Council, together with relevant departments, shall, through public bidding and other means, determine the enterprises, procurement prices and supply areas for the designated production of shortage drugs. Specific measures for fixed-point production shall be formulated by the competent department of industry and information technology under the State Council.
Article 119:[Emergency Production and Import] In the event of a disaster, epidemic situation, or other emergency, the competent department of health under the State Council may, in conjunction with relevant departments, coordinate with the holders of drug marketing authorizations and drug production enterprises to produce urgently needed shortage drugs, and coordinate with customs to handle the import of urgently needed shortage drugs.
Article 120:[Export Restrictions] The State Council may restrict or prohibit the export of drugs that are in short supply or consume scarce resources in China.
Article 121 [Compulsory Licensing of Patents] For the purpose of public health or in the event of a state of emergency in the country, the competent department of health under the State Council shall, on the basis of the needs of disease diagnosis and treatment, put forward a proposal for compulsory licensing of patents, and the enterprises with the corresponding conditions shall submit an application to the Patent Administration Department under the State Council, which may, in accordance with the provisions of Article 54 of the Patent Law of the People's Republic of China, implement the compulsory licensing of the patent for the drugs for which the patent right has been obtained. The drug supervision and administration department under the State Council shall give priority to the review and approval of drugs that have been granted compulsory patent licenses in accordance with regulations.
Article 122:[Supply of APIs] The State promotes the development and production of packaging materials and containers for the production of urgently needed and new types of medicinal raw materials, excipients, and direct-contact drugs, and encourages API production enterprises to directly supply APIs to pharmaceutical production enterprises.
The relevant departments of the State Council shall follow up and monitor the supply, inventory and market transactions of APIs, promptly discover and eliminate shortage risks, and investigate and deal with illegal acts such as monopoly and unfair competition of APIs in accordance with law.
Article 123:[Pricing Principles] For drugs that are subject to market-regulated prices in accordance with law, drug marketing authorization holders, drug production and trading enterprises, and user units shall formulate prices in accordance with the principles of fairness, reasonableness, good faith, and consistency of quality and price, and provide drugs with reasonable prices for drug users.
Holders of drug marketing authorizations, drug production and trading enterprises and user units shall comply with the provisions of the competent price department under the State Council on drug price management, clearly mark prices, and prohibit price fraud.
Article 124:[Price Supervision] The State Council's departments for market supervision and management shall strengthen supervision and inspection of drug prices, investigate and deal with illegal acts such as price monopolies, price fraud, and unfair competition in accordance with law, and maintain order in drug prices.
Article 125: [Reasonable Procurement Price Monitoring] Medical security departments shall adhere to the principle of demand-oriented and quality-oriented procurement of drugs in a centralized manner, reasonably determine drug prices with the market as the lead, establish and complete drug price monitoring systems, carry out drug price cost investigations, implement drug price and bidding and procurement credit evaluations, complete price adjustment and withdrawal mechanisms, and ensure drug quality and supply.
Article 126:[Fixed-point monitoring] When medical security departments carry out drug price monitoring, in order to grasp and analyze drug price changes and trends, they may designate some drug marketing authorization holders, drug production enterprises, drug distribution enterprises, and medical institutions as designated units for price monitoring;
Article 127:[Drug Donation] Donated drugs shall be varieties approved for marketing by the drug supervision and administration department under the State Council. The donor is responsible for the quality of the donated drug, and the donor is responsible for the use of the donated drug.
The transportation, storage and distribution of donated drugs shall comply with the relevant requirements of drug quality management, and donated drugs shall not be sold.
Chapter VIII: Supervision and Management
Article 128 [Detailed Article 124] The test referred to in item 4 of Article 124 of the Drug Administration Law refers to the test provided for in Article 68 of the Drug Administration Law.
Drugs that are prohibited for use as used in Item 5 of Article 124 of the Drug Administration Law refer to drugs that have already been listed after post-market evaluation or assessment and argumentation have been banned from listing by the drug supervision and administration department under the State Council and have their registration certificates cancelled for all drugs of that variety, or drugs that the drug supervision and administration department under the State Council stipulates shall not be listed in China.
Article 129:[Dispatching Agencies and Sub-Centers] The review and inspection branches established by the drug supervision and administration department under the State Council shall perform supervision and management duties such as review and approval, verification and inspection within the scope of authorization.
The drug supervision and management departments of the people's governments of provinces, autonomous regions, and municipalities directly under the Central Government may, as necessary for the performance of their duties, and with the approval of the people's governments at the same level, establish dispatch agencies authorizing them to perform drug supervision and management duties in relevant regions, carry out supervision and inspection in their own name, implement administrative penalties, and administrative compulsory measures related to administrative penalties.
Article 130:[ProfessionalIzed Teams of Specialized Inspectors] The teams of professional and specialized drug inspectors shall be managed at different levels and by category. The drug supervision and administration department shall, in accordance with the provisions of the drug supervision and administration department under the State Council, strictly enforce the standards for the entry of inspectors, strengthen the professional training of inspectors, and improve the ability level of inspectors.
The drug supervision and administration departments of the people's governments of provinces, autonomous regions, and municipalities directly under the Central Government shall, on the basis of regulatory powers, the scale of the pharmaceutical industry, and the inspection tasks, allocate sufficient inspectors to ensure the needs of the inspection work. Areas where there are high-risk drug manufacturers such as vaccines shall also be equipped with a corresponding number of inspectors with the skills and experience in the inspection of high-risk drugs such as vaccines.
Records formed by inspectors in accordance with procedures during on-site inspections and materials collected in accordance with law may be used as evidence for administrative law enforcement.
Article 131: [Supervision and Management Powers] Drug supervision and management departments and other departments may exercise the following functions and powers during supervision and inspection:
(1) Entering activity venues such as drug development, production, operation, and use, as well as production and business sites that provide relevant products or services for drug development, production, operation, and use, to carry out on-site inspections and take samples;
(2) Consulting, reproducing, sealing, or seizing documents and materials such as the development, production, operation, and use of drugs, as well as relevant contracts, bills, and account books; or requiring them to submit documents and materials related to the incident under investigation in a specified manner;
(3) Sealing or seizing drugs suspected of violating the law or having evidence to prove that there may be potential safety hazards, relevant raw materials, accessories, packaging materials and containers that directly contact drugs, and tools and equipment used for illegal activities;
(4) Seal up venues engaged in illegal activities.
When conducting supervision and inspections, law enforcement certificates shall be presented to keep the commercial secrets of the unit being inspected.
Relevant units and individuals shall cooperate with supervision and inspections, promptly provide relevant documents and materials in accordance with regulations, and must not conceal, refuse, or obstruct.
Article 132: [Supervision and Inspection of Drug Research Institutions] The drug supervision and administration department under the State Council organizes supervision and inspection of non-clinical safety evaluation research institutions for drugs. The drug supervision and management departments of the people's governments of provinces, autonomous regions, and municipalities directly under the Central Government shall carry out routine supervision and inspection of non-clinical safety evaluation and research institutions of drugs, and investigate and deal with illegal acts.
The drug supervision and administration department under the State Council and the competent department of health shall supervise and inspect drug clinical trial institutions in accordance with their duties. The drug supervision and management departments and health departments of the people's governments of provinces, autonomous regions, and municipalities directly under the Central Government shall, in accordance with their duties, carry out routine supervision and inspection of drug clinical trial institutions within their respective administrative regions, and investigate and deal with illegal acts.
Article 133: [Random Inspection and Inspection of Drug Quality] Random inspection and inspection of drug quality shall follow the principles of science, standardization, legality and justice.
The drug supervision and administration department shall formulate and implement a drug quality spot check and inspection plan according to the actual needs of drug supervision in the region, and clarify the payment method and payment time limit for the purchase of samples.
Drug sampling shall be carried out by two or more sampling personnel in accordance with the provisions of the drug supervision and administration department under the State Council. The unit being sampled shall cooperate with the sampling personnel to conduct sampling. If the unit being sampled does not cooperate without a legitimate reason, the relevant products shall be directly handled in accordance with the non-compliance requirements. The drug supervision and administration department under the State Council and the drug supervision and administration department of the people's government of the province, autonomous region, or municipality directly under the Central Government where the sampled unit is located may employ control measures such as suspension of production, sales, use, and import of the sampled unit.
According to the needs of supervision and management, the drug supervision and management department may conduct spot checks and inspections on the quality of APIs, related excipients, packaging materials and containers that are in direct contact with drugs.
Article 134:[Drug Spot Check and Re-inspection] Where the unit being sampled or the holder of the drug marketing authorization labeled by the drug has objections to the test results of the drug testing agency, it may submit an application for re-inspection within 7 days from the date of receipt of the drug test results.
Where an application is made for re-examination, the re-examination and inspection fee shall be paid in advance to the re-examination institution in accordance with the regulations. If the re-inspection conclusion is inconsistent with the original inspection conclusion, the cost of the re-inspection and inspection shall be borne by the original drug testing institution.
The drug inspection agency shall review the materials within 7 working days from the date of receipt of the application for re-inspection, accept those that meet the requirements, and inform the unit applying for re-examination and the drug supervision and management department that organizes the random inspection and inspection within 2 working days.
Where the drug supervision and administration department under the State Council stipulates that no re-examination shall be re-examined, it shall not be re-examined.
Article 135:[Drug Quality Announcement] The State Council and the drug supervision and administration departments of the people's governments of provinces, autonomous regions, and municipalities directly under the Central Government shall periodically publish the results of random inspections and inspections of drug quality.
The results of the drug quality spot check shall include the name of the drug being sampled and the holder of the marketing authorization of the marked drug, the source of the tested product, the labeling production enterprise, the production batch number, the drug specifications, the inspection agency, the inspection basis, the inspection conclusion, and the items that do not meet the regulations. Where the results of the drug quality spot check are improperly published, the issuing department shall correct them within the original scope within 5 days from the date of confirming the improperness.
The results of drug quality spot checks and inspections may be used as the basis for drug supervision and management departments to determine the quality of drugs.
Article 136:[Supplementary Inspection Methods] Where drugs suspected of adulteration or adulteration cannot be tested in accordance with the inspection items and inspection methods provided for in the drug standards, the drug inspection institution may use the supplementary inspection items and inspection methods approved by the drug supervision and administration department under the State Council to conduct inspections; the inspection conclusions drawn by using the supplementary inspection items and inspection methods may be used as the basis for determining the quality of the drugs.
Article 137: [Exploratory Research on Drug Sampling] According to the needs of regulatory work, drug inspection institutions may carry out exploratory research in response to possible quality problems in drugs, providing technical support for further improving the quality level of drugs and strengthening drug supervision.
Article 138:[Obligation of Administrative Counterparts to Cooperate] When the drug supervision and management department carries out supervision and inspection, the unit being inspected shall promptly follow the requirements of the drug supervision and management department, clarify the person in charge of the inspection site, open the relevant places or areas, cooperate with the inspection of relevant facilities and equipment, maintain the normal production and operation status, provide true, effective and complete documents, records, bills, vouchers, electronic data and other relevant materials, and truthfully answer the inspectors' inquiries.
Where the drug supervision and management department refuses or does not cooperate with the licensing inspection carried out by the drug supervision and management department in accordance with the law or whether it conforms to the relevant quality management standards, resulting in the inability to complete the inspection work, the relevant inspection content is directly handled as not conforming to the provisions and specification requirements.
Article 139: [Extended Inspection] When the drug supervision and management department conducts an extended inspection in accordance with article 99 of the Drug Administration Law, the units and individuals being inspected shall promptly follow the requirements of the drug supervision and management department, cooperate with the on-site inspection, provide true, effective and complete documents, records, bills, vouchers, electronic data and other relevant materials, and truthfully answer the inspectors' inquiries. If the inspected unit or individual refuses or does not cooperate, resulting in the inability to complete the inspection work, and the pharmaceutical production and operation enterprise cannot prove that the relevant production and operation activities meet the statutory requirements, the relevant inspection content is directly handled as not complying with the provisions and normative requirements.
Where during the extended inspection it is discovered that the unit or individual under inspection has violated laws and regulations, which shall be handled by the departments for market supervision and management and other departments in accordance with law, the drug supervision and management departments shall promptly notify them.
Article 140:[Measures for Handling After Supervision and Inspection] Where, through supervision and inspection, drug supervision and management departments discover that drug development, production, business, or use activities, or post-marketing management do not meet the requirements, and there is evidence to prove that there may be potential safety hazards, they may employ the following measures in accordance with law and record them in the drug safety credit archives:
(1) Employ measures such as warnings, interviews, and rectification within a time limit based on risks, requiring that potential safety hazards be eliminated in a timely manner;
(2) Where there are quality problems or other potential safety hazards in the drug, and the holder of the drug marketing authorization shall recall the drug in accordance with law but does not recall it, the drug supervision and management department of the people's government of the province, autonomous region or municipality directly under the Central Government shall order it to recall it;
(3) Where it is discovered that there are major potential safety hazards or there is evidence proving that there may be major potential safety hazards, employ measures such as suspending clinical trials of drugs or suspending the production, sale, use, or import of drugs;
(4) Where it is discovered that there are major illegal acts or major potential safety hazards that might seriously endanger public health, or are suspected of committing a crime, the Drug Supervision and Administration Department of the People's Government of the State Council and the people's governments of provinces, autonomous regions, and municipalities directly under the Central Government decide not to allow the legally-designated representatives, principal responsible persons, directly responsible supervisors, and other directly responsible personnel of the suspected illegal units from leaving the country, and notify the exit-entry administration organs;
(5) Other oversight and management measures that may be employed in accordance with law.
Where major drug quality and safety risks are discovered, the drug supervision and management department shall promptly report to the local people's government and the drug supervision and management department of the people's government at the level above.
Where it is discovered that a pharmaceutical production and trading enterprise has serious illegal conduct, it shall be investigated and dealt with in accordance with law, and entered into the list of untrustworthiness in accordance with regulations.
Article 141: [Responsibility Interview] Drug supervision and management departments may, on the basis of supervision and management, interview relevant units and individuals, and relevant units and individuals shall cooperate. The parties shall take timely measures according to the content of the interview and report to the drug supervision and management department. Where the parties concerned fail to take measures in a timely manner, the drug supervision and management department may disclose the content of the interview and adopt other supervision and management measures.
Interview refers to the administrative guidance behavior of the drug supervision and management department to meet with the legal representative or main responsible person of the enterprise for drug production and trading enterprises with potential safety hazards, point out problems, clarify requirements, and supervise rectification.
Article 142:[Suspension Period] Where drug supervision and management departments adopt measures such as suspending production, sales, use, or imports, they shall order drug production and trading enterprises to take effective measures to eliminate potential safety hazards. Where pharmaceutical production and trading enterprises eliminate potential safety hazards and meet relevant requirements after comprehensive assessment by the drug supervision and management departments, they shall lift risk control measures such as suspension of drug production, sales, use, and import.
Article 143:[Sealing and Seizure] Where drug supervision and management departments adopt measures for sealing and seizure in accordance with law, the period for sealing and seizure shall not exceed 90 days; in complicated cases, they may be extended by 30 days upon approval of the responsible person of the drug supervision and management department.
Article 144:[Information Disclosure of Commercial Secrets, etc.] The results of the examination and approval of drug administrative licenses shall be disclosed in accordance with law, and the review and approval process shall allow the applicant to inquire.
Without the consent of the applicant, the drug supervision and management departments, professional and technical institutions and their staff must not disclose the commercial secrets, undisclosed information or confidential business information submitted by the applicant, except as otherwise provided by law or involving national security or major social public interests.
Article 145:[Emergency Handling of Drug Safety Incidents] In the event of a drug safety incident related to drug quality, the holder of the drug marketing authorization and the drug production enterprise shall immediately adopt control measures such as sealing the relevant drugs and their raw materials, excipients, packaging materials and containers that directly contact the drugs, and related production lines, immediately carry out response and disposal, prevent the expansion of harm, find and analyze the causes, and report to the drug supervision and management department of the people's government of the province, autonomous region, or municipality directly under the Central Government Drug trading enterprises and user units shall immediately seal the relevant drugs, take effective measures such as recovering the drugs to prevent the expansion of harm, and report to the local drug supervision and management department and other departments.
The drug supervision and administration department shall report to the local people's government within 24 hours of receiving the report, and at the same time report to the drug supervision and management department of the people's government at the level above.
People's governments at the county level or above shall, in accordance with the emergency response plan for drug safety incidents, immediately organize and carry out response and disposal work.
Article 146:[Drug Supervision Fees] Fees may be collected for drug registration in accordance with the provisions of the Drug Administration Law and these Regulations. Specific fee items and standards shall be formulated by the financial department under the State Council and the competent department in charge of pricing in accordance with the relevant provisions of the State.
Article 147:[Cancellation of Drug Registration Certificate] In any of the following circumstances, the drug supervision and administration department under the State Council may cancel the drug registration certificate and publish it:
(1) The holder of the drug marketing authorization voluntarily proposes to cancel the drug registration certificate;
(2) Not re-registering or failing to apply for re-registration at the expiration of the validity period of the drug registration certificate;
(3) Where the drug registration certificate, drug production license, or other administrative licenses of the holder of the drug marketing license have been revoked or revoked in accordance with law;
(4) In accordance with the provisions of Article 83 of the Drug Administration Law, the efficacy is uncertain, the adverse reactions are large, or the human health is endangered for other reasons;
(5) In accordance with the provisions of Article 61 of the Vaccine Administration Law, after post-marketing evaluation, the abnormal reaction to vaccination is serious or other reasons endanger human health;
(6) In accordance with the provisions of Article 62 of the Vaccine Administration Law, after post-marketing evaluation, it is found that the product design, production process, safety, effectiveness or quality controllability of the vaccine variety is significantly inferior to that of other vaccine varieties for the prevention or control of the same disease;
(7) Failing to complete the corresponding research work within the prescribed time limit in accordance with the requirements of the drug approval certification documents or the requirements of the drug supervision and management departments, and there is no reasonable reason;
(8) Other circumstances in which the drug registration certificate shall be cancelled in accordance with law.
Article 148:[Cancellation of Approval Number of Preparations of Medical Institutions] In any of the following circumstances, the drug supervision and administration departments of the people's governments of provinces, autonomous regions, and municipalities directly under the Central Government may cancel the approval number of preparations of medical institutions and publish them:
(1) Where medical establishments voluntarily submit cancellations;
(2) not re-registration or failing to apply for re-registration upon the expiration of the validity period of the approval document number;
(3) Where medical establishments are terminated in accordance with law;
(4) Varieties already in supply on the market;
(5) Other circumstances where the approval document number shall be revoked in accordance with law.
Article 149:[Cancellation of Drug Production and Business Licenses] In any of the following circumstances, the drug supervision and administration departments may cancel the drug production license, the drug business license, or the preparation license of medical institutions, and publish it:
(1) Where pharmaceutical production enterprises, drug distribution enterprises, or medical establishments voluntarily apply for cancellation;
(2) Not reissuing a certificate or failing to apply for a new certificate at the expiration of the validity period of the permit;
(3) Where the enterprise or medical establishment terminates in accordance with law;
(4) Where the license has been revoked or revoked in accordance with law;
(5) Where a pharmaceutical trading enterprise terminates its drug dealings or fails to report closure for more than 12 months;
(6) Other circumstances where administrative licenses shall be revoked in accordance with law.
Article 150:[Failure to Renew on Schedule] Where the time for submitting an application for re-registration or re-issuance does not comply with the provisions of these Regulations, but the validity period of the license has not yet expired at the time of application, production and operation must not continue after the relevant license expires. Where the drug supervision and administration department approves re-registration or re-issuance of the certificate, it may produce and operate from the date of granting the license.
Article 151:[Linkage between Administrative Law Enforcement and Criminal Justice] Where drug supervision and management departments discover that drug violations are suspected of being a crime, they shall promptly transfer the case to the public security organs. Where relevant illegal conduct shall be given a warning, circulated for criticism, temporarily withheld or revoked licenses, lowered qualification levels, restricted the development of production and business activities, ordered to stop production and business, ordered to close, or restricted employment, the drug supervision and management departments may at the same time impose administrative punishments in accordance with law; where it is truly necessary to impose a fine first due to the handling of the case, the public security organs and people's procuratorates may, with the consent of the public security organs and the people's procuratorate, impose a fine in accordance with law. The administrative punishment of the drug supervision and management department does not affect the investigation and handling of suspected criminal acts.
Where criminal responsibility is not required or criminal punishment is waived in accordance with law, but administrative responsibility should be pursued, the public security organs, people's procuratorates, and people's courts shall promptly transfer the case to the drug supervision and management department. Where, after a criminal punishment is imposed, it is still necessary to pursue their administrative responsibility, the public security organs, people's procuratorates, and people's courts shall promptly transfer the case to the drug supervision and management department.
Drug supervision and management departments, public security organs, and people's procuratorates at all levels shall actively establish information sharing platforms linking administrative law enforcement and criminal justice, and promote the establishment of linkage mechanisms for the investigation and handling of cases such as information sharing, joint supervision, and communication and coordination.
Article 152:[Discipline Inspection and Supervision] Where drug supervision and management departments discover in the course of administrative law enforcement that a staff member is suspected of abusing his or her powers, engaging in malpractice for personal gain, dereliction of duty, or other clues of violations of law or discipline, such as failing to perform his duties in accordance with law or failing to perform his duties effectively, they shall promptly transfer the clues and evidentiary materials to the relevant discipline inspection and supervision organs in accordance with the requirements of the coordination mechanism for administrative law enforcement and discipline inspection and supervision, and assist and cooperate with the discipline inspection and supervision organs in carrying out investigation and handling work in accordance with law.
Chapter IX: Legal Liability
Article 153:[Sale of Prohibited Drugs] Where a drug trading enterprise retails drugs through online retailing, the drug supervision and administration department under the State Council stipulates that it is not allowed to retail drugs online, it shall be punished in accordance with Article 115 of the Drug Administration Law.
Article 154:[Penalties for Packaging Materials for Excipients] Where the packaging materials and containers of excipients or directly contact drugs do not meet the relevant quality requirements in the national drug standards or drug registration standards, the illegal products and illegal gains shall be confiscated, and a fine of between 10 times and 20 times the value of the goods shall be imposed, and where the value of the goods is less than 5,000 yuan, it shall be calculated as 5,000 yuan.
Where the above-mentioned products that do not meet the standards have been used in the production of drugs and do not constitute counterfeit or inferior drugs, the relevant drugs shall be handled in accordance with the provisions of Article 82 of the Drug Administration Law; if the good manufacturing practices of drugs are violated, penalties shall be given in accordance with the provisions of Article 126 of the Drug Administration Law.
Article 155 [Penalties for Changes Without Approval] The drug supervision and administration department under the State Council stipulates that the relevant changes shall be subject to permission, and where drug production enterprises, drug trading enterprises and medical institutions change matters related to drug production and operation without permission, the department that originally issued the license shall order them to complete the formalities for the change within a time limit and give punishment in accordance with the provisions of Article 115 of the Drug Administration Law.
Article 156:[Penalties for Violations of Standards and Norms] Where the production of Chinese medicine tablets without national drug standards does not conform to the preparation specifications formulated by the drug supervision and management departments of the people's governments of provinces, autonomous regions, or municipalities directly under the Central Government, or medical institutions do not formulate preparations in accordance with the standards approved by the drug supervision and management departments of the people's governments of provinces, autonomous regions, or municipalities directly under the Central Government, punishment shall be given in accordance with the provisions of Articles 117 and 118 of the Drug Administration Law.
Article 157:[Determination of Legal Liability for Chinese Medicine Tablets and Not Affecting Quality]
Paragraph 2 of Article 117 of the Drug Administration Law does not affect safety and effectiveness, which refers to the situation in which chinese medicine tablets comply with the provisions of item (7) of the third paragraph of article 98 of the Drug Administration Law, but the items that do not meet the drug standards are the size, surface color, or moisture, ash, and drug chips impurities in the characteristics or inspection items, and the differences with the requirements of the drug standards are within the scope stipulated by the drug supervision and management departments of the people's governments of provinces, autonomous regions, and municipalities directly under the Central Government.
Article 158:[Penalties for Submitting False Materials and Samples] Where in the course of clinical trials of drugs other than vaccines, applications for product marketing licenses, or applications for drug production and operation licenses, preparation licenses for medical institutions, import and export licenses for narcotic drugs and psychotropic substances, if the applicant provides false certificates, data, materials, samples, or has other deceptive conduct, the relevant application shall not be approved and shall be punished in accordance with Article 123 of the Drug Administration Law. Where the agent designated by the applicant falsifies certificates, data, materials, samples, or commits other deceptive acts, the relevant application shall not be approved, and the applicant or agent shall be punished in accordance with Article 123 of the Drug Administration Law.
In the process of certification of quality management norms for non-clinical research of drugs, if the applicant provides false application materials, he shall be punished in accordance with Article 123 of the Drug Administration Law.
Article 159:[Penalties for Failure or Destruction of Production Inspection Records] Whoever does not have a production inspection record or intentionally destroys a production inspection record shall be punished in accordance with the provisions of Article 124 of the Drug Administration Law.
Article 160:[Penalties for Failure to Comply with Pharmacovigilance Quality Management Norms] Where drug marketing authorization holders or other units fail to comply with the pharmacovigilance quality management norms, they shall be punished in accordance with Article 126 of the Drug Administration Law.
Article 161 [Determination of Failure to Comply with Quality Management Norms] Where the research and development or production and operation activities of the drug marketing authorization holder or other units do not meet the requirements of the general projects in the relevant quality management standards, and the drug supervision and management department determines that it can meet the requirements after rectification, it shall not be punished. Where the research and development or production and operation activities do not meet the requirements of key projects and key projects in the quality management standards, they shall be ordered to rectify in accordance with the procedures; among them, if the quality management system cannot be effectively implemented and does not meet the basic requirements of the quality management standards, it shall be punished in accordance with the provisions of Article 126 of the Drug Administration Law.
If the drug supervision and management department discovers that the research and development or production and operation activities do not conform to the provisions of the key projects and key projects in the quality management specifications during the licensing inspection, it shall order rectification and reform, and temporarily refuse to license or not license in accordance with the regulations, and may not be punished.
In the course of supervision and inspection of drug clinical trial institutions, if it is found that the filing conditions are not met or it is not suitable to continue to undertake drug clinical trials, the filing of its drug clinical trial institutions or relevant clinical trials majors shall be cancelled, and the filing shall not be handled within 1 year.
Article 162:[Penalties for Illegal Packaging, Labeling, and Instructions] Where pharmaceutical production enterprises, drug distribution enterprises, and pharmaceutical distribution enterprises produce or trade drugs, as well as preparations prepared by medical institutions, whose packaging, labeling, and instructions violate the provisions of the Drug Administration Law and these Regulations, they shall be punished in accordance with the provisions of Article 128 of the Drug Administration Law.
Article 163:[Penalties for Unauthorized Use of Preparations] Where a medical institution uses a preparation prepared by another medical institution without approval, it shall be punished in accordance with the provisions of Article 129 of the Drug Administration Law.
Article 164:[Refusal to Enforce Penalty Rules] In any of the following circumstances, the drug supervision and management department shall confiscate the drugs used in illegal production and operation, and impose a fine of not less than 10 times but not more than 20 times the value of the drugs used in illegal production and operation; if the value of the goods is less than 100,000 yuan, it shall be calculated as 100,000 yuan; if the circumstances are serious, order the suspension of production and business for rectification until the drug approval documents, drug production licenses, and drug business licenses are revoked, and the legal representative, the principal responsible person, The directly responsible supervisors and other responsible personnel shall confiscate the income obtained from their own units during the illegal act, and impose a fine of not less than 30% but not more than 3 times the income obtained, and prohibit them from engaging in pharmaceutical production and business activities for 10 years:
(1) After the drug supervision and administration department orders the suspension of production, operation, import, or use, it still refuses to stop production, operation, import, or use;
(2) Refusing to carry out the post-marketing evaluation of drugs ordered by the drug supervision and management departments.
Article 165:[Penalties for Pharmacists Who Fail to Allocate Prescriptions in Accordance with Regulations] Where pharmacists or other pharmaceutical technicians who have undergone qualifications in accordance with the law fail to allocate prescriptions in accordance with the provisions of the Drug Administration Law, the drug supervision and management department and the competent department of health shall, in accordance with the division of duties, order the suspension of practice activities for 6 months to 1 year, and may also impose a fine of between 1,000 and 20,000 yuan, and the unit to which they belong or their superior unit shall give disciplinary punishment;
Article 166:[Heavier] Whoever violates the provisions of the Drug Administration Law and these Regulations and commits any of the following acts shall be given a heavier punishment within the range of punishment provided for in the Drug Administration Law and these Regulations:
(1) Producing, selling, or using counterfeit or inferior drugs whose main objects of use are pregnant women or children;
(2) Biological products produced, sold, or used are counterfeit or inferior drugs;
(3) Producing, selling, or using counterfeit or inferior drugs, causing consequences of personal injury;
(4) Producing, selling, or using counterfeit or inferior drugs, and re-offending them after being dealt with.
Article 167:[Mitigating Punishment] Where drug marketing authorization holders, drug production enterprises, drug distribution enterprises, and medical institutions stop production or business in accordance with the provisions of the first paragraph of Article 82 of the Drug Administration Law, carry out drug recalls, or take other effective measures to mitigate or eliminate drug safety risks, and no harmful consequences are caused, the punishment may be mitigated or mitigated.
Article 168:[No Punishment] Where the illegal conduct is minor and is promptly corrected, and no harmful consequences are caused, administrative punishment is not given. Where the law is violated for the first time and the harmful consequences are minor and are promptly corrected, administrative punishment may not be given.
Where the parties have sufficient evidence to prove that they have fully performed their duties, have no subjective fault, have not caused harmful consequences, or that the harmful consequences are significantly minor, administrative punishment is not given.
Where administrative punishment is not given to a party for illegal conduct in accordance with law, the drug supervision and management department shall educate the party concerned.
Article 169:[Exemption from Punishment] Where pharmaceutical trading enterprises or medical institutions have not violated the relevant provisions of the Drug Administration Law and these Regulations, and have sufficient evidence to prove that they do not know that the drugs they are selling or using are counterfeit or inferior drugs, they shall confiscate the counterfeit drugs, inferior drugs, and illegal gains they sell or use; they may be exempted from administrative punishment.
Article 170:[Quality Inspection Report] Where counterfeit drugs are determined to be counterfeit according to subparagraphs (4) of the second paragraph of article 98 of the Drug Administration Law, and those identified as inferior drugs according to items (3) to (5) of the third paragraph of article 98 of the Drug Administration Law, there is no need to test the drugs involved in the case. Where drugs are identified as counterfeit or inferior drugs in accordance with other provisions of Article 98 of the Drug Administration Law, and there is evidence such as records of the procurement and use of raw materials, excipients, and feeding records that fully prove that the drugs do not comply with the provisions of laws, regulations, and standards, the drugs involved in the case may not be inspected.
Article 171:[Unlawful Gains] Unlawful gains shall be calculated on the basis of all income obtained by drug marketing authorization holders, drug production enterprises, drug distribution enterprises, and medical institutions from illegal production and sale of drugs or the provision of services, and the amounts that must be paid by the State, such as taxes and social insurance funds already paid by the parties, may be deducted.
Article 172:[Principal Responsible Person] The principal responsible person provided for in the Drug Administration Law refers to a person who is fully responsible for the organization and operation management of an enterprise and who can actually control the company's behavior. If the actual controller of an enterprise is a legal person, the main person in charge refers to the main person in charge of the actual controller.
Article 173:[Serious Circumstances] The following circumstances are serious circumstances provided for in the Drug Administration Law:
(1) Those who have been punished many times and have no will to repent;
(2) Causing serious consequences;
(3) Causing a major social impact;
(4) Resisting or evading the lawful exercise of supervision, inspection, or investigation authority by the drug supervision and management departments and their staff, or fabricating, destroying, or concealing relevant evidentiary materials;
(5) Using sealed or seized articles without authorization, making it difficult to recover the product, making it difficult to eliminate harm, or causing serious consequences;
(6) Other situations of serious violation of the Drug Administration Law.
Article 174:[Detention Procedures] Pursuant to articles 118, 122, 123, and 124 of the Drug Administration Law, where the drug supervision and administration department finds that administrative detention should be given in accordance with law, it shall transfer the relevant materials of the case to the public security organ at the same level and submit a written opinion recommending administrative detention; the public security organ shall transfer the public security organ to the place of jurisdiction to make a decision on administrative detention in accordance with procedures and implement it.
Article 175:[Handling of Confiscated Articles] Articles confiscated in accordance with the provisions of the Drug Administration Law and these Regulations shall be supervised and handled by the drug supervision and management departments in accordance with the regulations.
Article 176:[Partial Reduction of Production and Business Scope] In accordance with the provisions of the Drug Administration Law and these Regulations, the drug production and operation license may be revoked, and if the drug supervision and management department finds that the illegal act only involves some products or production and business activities, and is not enough or does not need to revoke all licenses, it may make a decision to partially reduce the scope of production and operation.
Article 177:[Date of Commencement of Prohibition of Business Penalties] Where the drug supervision and administration department makes a decision to prohibit relevant responsible persons from engaging in drug production and business activities for a certain period of time in accordance with the provisions of the Drug Administration Law and these Regulations, the specific period is calculated from the date on which the administrative punishment decision takes effect; where the relevant responsible personnel are sentenced to administrative detention, criminal detention, or fixed-term imprisonment, the time limit is calculated from the day after the completion of administrative detention or the relevant criminal punishment.
Article 178:[Penalties for Leaking Data] Where the drug supervision and management department and its staff violate regulations by leaking undisclosed test data or other data, causing losses to the applicant, the drug supervision and management department shall bear the liability for compensation in accordance with law; after the drug supervision and management department compensates for the loss, it shall order the staff who intentionally or grossly negligently bear part or all of the compensation costs, and give administrative sanctions to the directly responsible personnel in accordance with law.
Chapter X Supplementary Provisions
Article 179:[Export Administration] Drugs exported shall comply with the standards or contractual requirements of the importing country (region).
Article 180:[Treaty Obligations] Where international treaties concluded or acceded to by the People's Republic of China have different provisions from the Drug Administration Law and these Regulations, the provisions of the international treaties shall apply, except for the provisions of the Reservation Declared by the People's Republic of China.
Article 181:[Time of Entry into Force] These Regulations shall enter into force on ×, ×, ×.
Source: NmPA website
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