Announcement of the National Medical Products Administration, Ministry of Agriculture and Rural Affairs, National Forestry and Grassland Administration, and National Administration of Traditional Chinese Medicine on Issuing the Good Agricultural Practice for Chinese Crude Drugs
In order to implement the Opinions of the CPC Central Committee and the State Council on Promoting the Inheritance, Innovation and Development of Traditional Chinese Medicine, promote the regulated manufacturing of Chinese crude drugs, strengthen the quality control of Chinese crude drugs, and promote the highquality development of traditional Chinese medicine, the National Medical Products Administration, Ministry of Agriculture and Rural Affairs, National Forestry and Grassland Administration, and National Administration of Traditional Chinese Medicine formulated the Good Agricultural Practice (hereinafter referred to as the GAP) in accordance with the Drug Administration Law of the People's Republic of China and Law of the People's Republic of China on Traditional Chinese Medicine, which was promulgated and implemented on March 1, 2022, and the relevant issues are hereby announced as follows:
I. The GAP is applicable to the whole process management of regulated manufacturing of Chinese crude drugs by Chinese crude drugs manufacturers, and is the basic requirement of regulated manufacturing and management of Chinese crude drugs. The Chinese crude drugs in the GAP refer to the medicinal raw materials derived from medicinal plants, medicinal animals and other resources and used for the manufacturing of prepared slices of Chinese crude drugs and preparations after standardized planting (including ecological planting, wild cultivation and imitated wild cultivation), breeding, harvesting and processing in the manufacturing place.
Chinese crude drugs manufacturers in this announcement include planting and breeding specialized cooperatives or cooperatives with the nature of an enterprise.
II. Manufacturers of prepared slices of Chinese crude drugs, marketing authorization holders of Chinese patent medicine are encouraged to build or jointly build manufacturers and manufacturing bases of Chinese crude drugs at the place of origin of Chinese crude drugs in accordance with the GAP, and extend the drug quality management system to the place of origin of Chinese crude drugs.
TCM manufacturers are encouraged to give priority to the use of Chinese crude drugs that meet the GAP requirements. Where there are explicit requirements in the drug approval documents, TCM manufacturers should use the Chinese crude drugs that meet the GAP requirements according to the provisions. Relevant TCM manufacturers should carry out supplier audit according to law and conduct audit and inspection in accordance with the GAP requirements to ensure the compliance with the requirements.
III. For the use of Chinese crude drugs that meet the GAP requirements, the relevant TCM manufacturers can refer to the relevant provisions on drug label management, mark the information "crude drugs meet the GAP requirements" at the appropriate position of the drug label, and promote it according to law. For TCM compound preparations, all the ingredients in the formula should meet the GAP requirements before marked with "meet GAP requirements".
Provincial drug regulatory departments should strengthen supervision and inspection, and when necessary, may carry out extended inspection on the corresponding TCM manufacturers that should use or mark the use of Chinese crude drugs that meet the GAP, with emphasis on whether they meet the GAP or not. In case of identifying any inconformity, the drug regulatory departments shall conduct severe investigation and punishment according to law, order the TCM manufacturer to make rectification within a prescribed time limit, cancel the labeling, etc., and disclose the information of corresponding manufacturers of Chinese crude drugs and their varieties of Chinese crude drugs, and notify the people's government of the place of origin of Chinese crude drugs.
IV. Under the leadership of the provincial Party Committee and the provincial government, the relevant administrative departments of each province should cooperate with and assist the people's government of the place of origin of Chinese crude drugs to achieve regulated development of Chinese crude drugs, such as improving the working mechanism for high-quality development of Chinese crude drugs industry; formulating the development plan for Chinese medicine materials industry; refining the incentive policies to promote the regulated development of Chinese crude drugs; establishing a standing book and credit archives for TCM manufacturers and their manufacturing bases to implement dynamic supervision; and establishing an information platform for regulated manufacturing and traceability for Chinese crude drugs. Provinces with a better basis for regulated and intensive manufacturing of Chinese crude drugs are encouraged to study and formulate implementation rules based on the actual development of Chinese crude drugs in the areas under their jurisdiction, and make active exploration and promotion, so as to accumulate experiences for further promotion of the GAP.
V. The relevant administrative departments of each province should conduct inspection and provide technical guidance on the implementation and promotion of the GAP according to their responsibilities. Relevant authorities of Ministry of Agriculture and Rural Affairs should take the lead in providing guidance on the supply of seeds, seedlings and provenances of Chinese crude drugs, field management, use of pesticides and fertilizers, and pest control. Relevant authorities of the National Forestry and Grassland Administration should take the lead in providing guidance on ecological planting, wild cultivation and imitated wild cultivation of Chinese crude drugs, as well as planting and breeding of Chinese crude drugs under the management category of endangered plants. TCM regulatory authorities should work together to provide guidance on seeds and seeding, standardized planting, harvesting and processing, and ecological planting of Chinese crude drugs. The drug regulatory departments should carry out extended inspections on the corresponding manufacturers of Chinese crude drugs, and provide guidance on the requirements for medicinal use, processing in the place of origin and quality inspection.
VI. The relevant administrative departments of each province should strengthen cooperation to form a joint force, jointly promote the regulated, standardized and intensive development of Chinese crude drugs, enhance publicity and training according to their responsibilities, and promote the implementation of the GAP. The relevant administrative departments of each province should strengthen the routine supervision during the implementation. In case identifying any major problems or suggestions on the improvement of major policies, please report to the corresponding management department of the State in time.