Recently, after extensive solicitation of opinions and repeated demonstration and evaluation, the State Food and Drug Administration issued the "Announcement on Further Improving the Work Related to the Supervision and Administration of Drug Operation" (hereinafter referred to as the "Announcement"), which further clarified and refined the implementation standards and work requirements of the "Measures for the Supervision and Administration of Drug Operation and Use Quality" (hereinafter referred to as the "Measures").
The "Announcement" focuses on the current situation and problems faced by drug operation and supervision, and on the basis of summarizing and solidifying the practical experience and achievements of drug circulation supervision, responds to industry concerns, strengthens risk management, and promotes high-quality development, laying a solid foundation for the regulatory authorities to unify their thinking and understanding and implement scientific supervision.
Part.01
Adhere to high-quality development
Combined with intensive use of resources
Clarifying access requirements, coordinating and integrating resources, and improving the concentration and management modernization level of the wholesale industry are the regulatory ideas conveyed by the Announcement. Engaging in wholesale business should have the requirements of modern logistics self-operated warehouses, which is one of the key points and highlights of the "Measures", and is also the focus of attention and discussion of the industry and regulatory authorities. In recent years, the state has been attaching great importance to promoting the large-scale and intensive development of the drug wholesale industry, guiding and optimizing the layout of the drug circulation industry through the issuance of plans and opinions, and deepening the construction of logistics infrastructure network in the field of drug circulation. The "Announcement" makes it clear that the foothold of the newly established wholesale enterprise with its own warehouse is "the operation and management of the company's personnel", emphasizing the "right to use" rather than "property rights", which not only consolidates the direct responsibility and main responsibility of the enterprise for the whole process management of drug warehousing, warehousing and delivery, but also avoids the additional burden of duplicate construction and asset costs on the enterprise. In addition, the formulation of the "announcement" also fully considers the current situation of the industry, especially the actual operation of small and medium-sized wholesale enterprises, encourages drug wholesale enterprises to integrate existing resources, upgrade facilities and equipment in the development, and gradually achieve modern logistics conditions, avoid the waste of resources caused by a large amount of cost investment in a short period of time, and encourage the professional advantages of third-party logistics of drugs, so as to make overall planning and steadily promote the construction of an efficient drug supply chain network.
The relevant requirements of the Announcement aim to establish an integrated management model of batch and zero with an independent system and shared facilities and equipment. In recent years, the development trend of online and offline integration and flattening of the pharmaceutical supply chain is obvious, coupled with the demand for diversified business development in the process of group development, and the integrated model of batch and zero has become a hot spot in the industry. Due to the basic principle of drug classification management, the key elements of drug wholesale and retail quality management are quite different, and for the regulatory authorities, it is necessary to clarify the grasp of "separation" and "integration" in integrated management. On the basis of fully analyzing the standards, facilities, personnel, quality management system and other requirements of drug wholesale and retail, the "Announcement" pointed out that wholesale and retail enterprises should establish wholesale and retail quality management systems respectively, set up warehouses that meet the actual needs of operation, and effectively prevent confusion and errors.
Part.02
Insist on strengthening risk management
Combined with innovative regulatory concepts
The "Announcement" emphasizes the key point control of high-risk products and links. In the retail operation of high-risk products, the "Announcement" puts forward targeted licensing conditions in terms of personnel qualifications and traceability capabilities. Especially for cell therapy biological products, fully considering the professionalism and particularity of their mechanism of action, preparation process, storage conditions, use methods, etc., drug retail enterprises operating cell therapy biological products are required to have the conditions for interconnection and interoperability with electronic prescription information of designated medical institutions, and are equipped with microbiology, immunology, preventive medicine, Licensed pharmacists with a bachelor's degree or above in clinical medicine and who have undergone the training and assessment of drug marketing authorization holders should guide professional pharmacies to achieve the operation and service capabilities suitable for special types of products, so as to fully ensure the safety of drug use by the people. In terms of entrusted storage and transportation, the "Announcement" clearly puts forward the quality control requirements of quality agreements and audits, computer system data docking, etc., and also refines the specific content of quality audits such as storage conditions, means of transportation, transportation methods, process temperature control and data record management for the entrusted storage and transportation related licenses, reports and cross-provincial collaborative supervision.
The announcement also encourages the use of information technology to improve the management level of the industry. The application of informatization and digital technology is an important engine to stimulate the vitality of the industry and an important means to enhance the ability of scientific supervision. The "Announcement" mainly puts forward the application scenarios of information management from the aspects of electronic exchange of first data, traceability of the whole process of key products, and on-the-job monitoring of pharmaceutical services, which not only guides the efficient operation and management of the industry, but also provides useful inspiration for the regulatory authorities to innovate and apply digital supervision methods.
Part.03
Adhere to the unity of standards
Combined with the implementation of local regulatory responsibilities
In terms of promoting the standardization and systematic management of licensing information, the "Announcement" clarifies that if a drug wholesale enterprise obtains the business scope of chemical drugs, it can operate chemical raw materials, unifies the expression of specific categories such as poppy husks, toxic Chinese medicine decoction pieces, and refrigeration and freezing scope in the business scope of the license, and clearly requires all business license information to be uploaded to the national drug regulatory data sharing platform within 10 days, so as to carry out cross-regional and online and offline integrated operation for enterprises, and smooth the "big market and big circulation" The supply chain network provides institutional guarantees.
The "Announcement" combines the actual situation to promote the implementation of local regulatory responsibilities. For drug wholesale and chain enterprises to set up warehouses across provinces, on the basis of meeting the basic conditions for setting up warehouses where the enterprises are located and the warehouses are located, the drug regulatory departments of the two places are required to communicate and negotiate, and rely on territorial responsibilities to ensure the landing and supervision of warehouses in different places. In terms of institutional standards, on the basis of unified working principles, fully considering the differences in local industrial levels and regulatory conditions, the "Announcement" encourages drug regulatory departments at all levels to formulate supporting documents in combination with the actual work, improve work processes and standards, and build a multi-level and operable institutional system.
To sum up, the "Announcement" fully follows the legislative spirit of the "Measures", highlights the close integration with the actual industry and high-quality development, and strives to solve and guide the new situations and new problems encountered in the supervision of drug business, which is an important basis for the current drug business supervision. The drug regulatory authorities should fully learn and understand, strengthen publicity and implementation, consolidate the responsibilities of all parties in business activities, integrate the concepts of legal supervision and scientific supervision into regulatory practice, help industry innovation and high-quality development, and effectively safeguard the health rights and interests of the people.
Source: China Food and Drug Network