Recently, the State Food and Drug Administration and the State Administration of Traditional Chinese Medicine jointly issued the newly revised "Measures for the Administration of Regional Folk Medicinal Materials" (hereinafter referred to as the "Measures"), which will be implemented from November 1, 2024. In 1987, the "Measures for the Management of Regional Folk Medicinal Materials (Trial)" was repealed at the same time.
According to the "Measures", regional folk medicinal materials refer to Chinese medicinal materials that have been recorded in materia medica, medical records, prescriptions, etc., and are not included in the national drug standards and do not have drug registration standards, but have many years of medicinal habits in local areas. The term "traditional Chinese medicine" includes the medicine of ethnic minorities, and Chinese herbal medicines include the medicinal materials of ethnic minorities.
The "Measures" clarify the overall requirements for the formulation of regional standards for folk medicinal materials, and prohibit varieties that have no history of local habitual use or lack of safety, functional indications or research to be included in the provincial standards for Chinese herbal medicines; The principles for the formulation and revision of provincial standards for Chinese herbal medicines are proposed, and the standards for new varieties are refined, the format, terminology and content of the standards, the names of medicinal materials included in the standards, as well as the requirements for standard filing, information disclosure, and standard improvement.
The "Measures" determine the channel for the provincial standard of Chinese herbal medicines to be upgraded to the national drug standard, require the provincial drug regulatory department to adjust the varieties of the provincial Chinese herbal medicine standard in a timely manner according to the varieties of medicinal materials included in the national drug standard, and stipulate the abolition of the provincial standard for Chinese herbal medicines. In terms of production and use management, the "Measures" clarify the requirements for the harvesting, processing, operation, purchase and use of regional folk medicinal materials.
It is worth noting that the "Measures" no longer approve the cross-provincial use of regional folk medicinal materials, and put forward relevant requirements for the management of cross-provincial use. According to its provisions, in principle, regional folk medicinal materials should be used within the administrative area of the provincial drug regulatory department where the place of origin is located, and if there is a clinical need for it, it can be used across provinces (autonomous regions and municipalities directly under the Central Government). For cross-provincial (autonomous region, municipality directly under the Central Government), the marketing authorization holder and the drug manufacturer shall implement a traceability system to ensure that the traditional Chinese medicine decoction pieces and preparations related to regional folk medicinal materials can be traced.
The "Measures" point out that local drug regulatory departments at all levels should strengthen the supervision of regional folk medicinal materials that enter the field of drug circulation and production within their respective administrative regions, and if necessary, carry out extended inspections on the regional folk medicinal materials purchased and used by drug marketing authorization holders, drug manufacturers and medical institutions within their respective administrative regions to ensure drug quality and drug safety.
Policy Interpretation
1. What is the background of the revision of the Measures for the Management of Regional Folk Medicinal Materials (hereinafter referred to as the "Measures")?
The mainland has a vast territory, complex geographical environment and diverse cultures, and many local characteristic medicinal materials have been discovered through long-term clinical practice. In order to strengthen the management of regional folk medicinal materials, since the 60s of the last century, individual provinces have begun to formulate and promulgate provincial standards for Chinese herbal medicines, and the former Ministry of Health also issued the "Measures for the Management of Regional Folk Medicinal Materials (Trial)" in 1987. According to the measures, almost all provinces in the country have promulgated provincial standards for Chinese herbal medicines. By the end of 2023, a total of 6,596 provincial-level standards for Chinese herbal medicines have been formulated. This not only excavates and sorts out the local medicinal resources to meet the needs of clinical regional drug characteristics, but also effectively supplements the national drug standards, which plays a positive role in ensuring drug safety.
In addition, regional folk medicinal materials are also one of the important sources of Chinese herbal medicines for rural Chinese medicine technicians to grow and collect for their own use. In 2006, the State Administration of Traditional Chinese Medicine, together with the former Ministry of Health, issued the Notice on Strengthening the Management of Chinese Herbal Medicines for Self-planting, Self-collection and Self-use by Rural Traditional Chinese Medicine Technicians. The Law of the People's Republic of China on Traditional Chinese Medicine, implemented in 2017, also clearly stipulates self-cultivation and self-harvesting of local Chinese herbal medicines. The Drug Administration Law of the People's Republic of China, revised in 2019, stipulates that the measures for the management of regional folk medicinal materials shall be formulated by the drug regulatory department of the State Council in conjunction with the national competent department of traditional Chinese medicine.
With the improvement of the above-mentioned laws and regulations and the development of traditional Chinese medicine, part of the original measures can no longer meet the needs of the current high-quality development of regional folk medicinal materials, and is also incompatible with the overall requirements of the supervision of medicinal materials.
2. What are the main contents of the Measures?
The "Measures" include 5 chapters of General Provisions, Standard Management, Production and Use Management, Supervision and Management and Supplementary Provisions, with a total of 30 articles, which greatly enriches the content of the original Measures (a total of 8 articles). First, the general provisions. It further clarifies the specific connotation of regional folk medicinal materials, the scope of application of the Measures, and the general requirements for the formulation of standards for regional folk medicinal materials, and at the same time, according to the characteristics of regional folk medicinal materials, the sustainable development of medicinal materials resources is clarified, and the management of self-planted and self-used varieties is clarified according to legal documents. The second is standard management. From the scope of medicinal materials, the name of medicinal materials, the filing of standards, the improvement of standards, the abolition of standards and other aspects, the whole life cycle management of provincial Chinese herbal medicine standards is further standardized. The third is production and use management. The harvesting, processing, procurement and use, cross-provincial use, labeling, and implementation standards of regional folk medicinal materials were clarified. Fourth, supervision and management. It clarifies the main body and regulatory measures of regional folk medicinal materials, and encourages local governments to carry out dynamic monitoring and quality monitoring of medicinal material resources. Fifth, supplementary provisions. It mainly connects the newly discovered medicinal materials, new drug registration and standard management of regional folk medicinal materials with the registration management and standard management documents of traditional Chinese medicine, so that the management of medicinal materials becomes an organic whole.
3. What is the connotation of regional folk medicinal materials?
In addition to being medicinal, Chinese medicinal materials also have the attributes of agricultural and sideline products. The regional folk medicinal materials to which the Measures apply take into account the characteristics of "regional folk customs" and "medicinal use", emphasizing the history of use, that is, "being recorded by Materia Medica, medical records, prescriptions, etc.", and at the same time emphasizing the regionality of medicinal use, that is, "Chinese herbal medicines that are not included in the national drug standards and do not have drug registration standards, but have many years of medicinal habits in local areas". From the perspective of standards, based on the definition of regional folk medicinal materials, including varieties with provincial standards for Chinese herbal medicines and those that do not yet have legal standards. In addition, according to the relevant provisions of the Law of the People's Republic of China on Traditional Chinese Medicine, rural Chinese medicine technicians can grow and collect Chinese herbal medicines for their own use. Considering that the current legal documents mainly use the management of rural medical institutions, the "Measures" only make a statement in principle, and other contents are linked to the existing provisions. It should be noted that the term "traditional Chinese medicine" in the "Measures" includes the medicine of ethnic minorities, and Chinese herbal medicines include the medicinal materials of ethnic minorities.
Fourth, can regional folk medicinal materials be used across provinces?
Over the years, the industry has had certain demands for simplifying the management of the cross-provincial use of regional folk medicinal materials, and there are also certain needs for doctors practicing across provinces and preparing prescriptions in medical institutions in clinical practice. The "Measures" adhere to the problem-oriented and goal-oriented, no longer implement the approval of the cross-provincial use of regional folk medicinal materials, emphasizing that in principle, they should be used within the province where the place of origin is located, and if there is a clinical use demand, it can be used across provinces. At the same time, in order to control the risks that may be brought about by inter-provincial use, it is necessary to strengthen management on the basis of its source can be checked, and drug marketing authorization holders and drug manufacturers for inter-provincial use should implement a traceability system to ensure that the whereabouts of the corresponding Chinese medicine decoction pieces and preparations can be traced.
5. How to determine the implementation standards of regional folk medicinal materials?
Chinese herbal medicines need to be concocted into Chinese medicine decoction pieces for clinical use, and the area of use of Chinese medicine decoction pieces varies with the clinical practice of Chinese medicine and changes with the school of Chinese medicine, and the place of use of Chinese medicine decoction pieces may be different from the origin of Chinese herbal medicines. For regional folk medicinal materials, most varieties are used in the same place and place of origin, but there are also some varieties that are used in different places and places of origin. At the same time, in order to avoid the drug safety problems that may be brought about by "foreign bodies with the same name" in different regions, the "Measures" fully respect the above-mentioned characteristics of regional folk medicinal materials, and also fully consider the positioning of Chinese herbal medicines in clinical services, and at the same time, in order to avoid the drug safety problems that may be brought about by "foreign bodies with the same name" in different regions, it is clarified that "if the provincial drug regulatory department where the regional folk medicinal materials are used has formulated the provincial standards for Chinese herbal medicines, it shall comply with the provincial standards for Chinese herbal medicines in the place where they are used." If the provincial drug regulatory department at the place of use does not formulate the corresponding standards, it shall comply with the provincial standards for Chinese herbal medicines at the place of production", and require the Chinese herbal medicine manufacturers to indicate the place of origin and the implementation of standards and other information in the labels of Chinese herbal medicines. This provision also clarifies the basis for drug inspection institutions to carry out inspections.
6. What is the relationship between the management of regional folk medicinal materials and the management of standards, and the registration and management of traditional Chinese medicines?
First, for varieties that have historical habits within the administrative area and there is no standard at present, the provincial drug regulatory department shall formulate provincial standards for Chinese herbal medicines after organizing research or research on their safety and functional indications; In addition, the research and development unit can also voluntarily carry out research in accordance with the relevant provisions and technical requirements of the registration of traditional Chinese medicine, and then apply for the registration of new medicinal materials; If the herbal medicine and other medicinal flavor formulas are declared as new Chinese medicine compound drugs, they shall be handled in accordance with the relevant requirements of the registration and management of Chinese medicines.
In 2015, the General Office of the former Food and Drug Administration issued the "Notice on Strengthening the Management of Local Medicinal Material Standards" (Food and Drug Administration Yaohua Guan [2015] No. 9), which clearly prohibits inclusion in the provincial standards for Chinese herbal medicines. The Measures also strengthen this requirement. For such varieties that have no historical habits, they should not be included in the provincial standards for Chinese herbal medicines, but need to be approved and managed to ensure safety, effectiveness and controllable quality.
The third is to consider that the "Measures for the Administration of Drug Standards" has been issued, and the special provisions on the standard management of traditional Chinese medicine are also being drafted.
7. What are the regulatory measures for regional folk medicinal materials?
The first is to strictly manage the standards, and make it clear that varieties that have no history of use in the region or lack of safety and functional indication research or research are prohibited from being included in the provincial standards for Chinese herbal medicines. The second is to implement the responsibilities of all parties, consolidate the responsibilities of Chinese herbal medicine manufacturers related to regional folk medicinal materials, as well as drug marketing authorization holders, Chinese medicine decoction piece manufacturers, and medical institutions that purchase and use regional folk medicinal materials, so as to ensure the quality of medicinal materials. The third is to strengthen supervision, local drug regulatory departments at all levels should strengthen the supervision of regional folk medicinal materials that have entered the field of drug circulation and production within their respective administrative regions, and if necessary, carry out extended inspections on the regional folk medicinal materials purchased and used by drug marketing authorization holders, Chinese medicine decoction piece manufacturers and medical institutions within their respective administrative regions. At the same time, strengthen the monitoring of adverse reactions of traditional Chinese medicine decoction pieces and preparations related to regional folk medicinal materials, and organize and deal with the risk signals found in a timely manner to ensure the quality and safety of drugs.
Edit | Zhang Zhiying Editor-in-charge| Zhang Xiuli
Source | The official website of the National Medical Products Administration, China Medical News
Produced by the Guangdong Health Online all-media team