On March 17, 2022, the National Medical Products Administration (NMPA), the Ministry of Agriculture and Rural Affairs, the National Forestry and Grassland Administration, and the National Administration of Traditional Chinese Medicine jointly issued an announcement regarding the "Good Agricultural Practice for Chinese Herbal Medicines."

The original text is as follows:

To implement the "Opinions of the Central Committee of the Communist Party of China and the State Council on Promoting the Inheritance, Innovation, and Development of Traditional Chinese Medicine," standardize the production of Chinese herbal medicines, strengthen the quality control of Chinese herbal medicines, and promote the high-quality development of traditional Chinese medicine (TCM), in accordance with the "Drug Administration Law of the People's Republic of China" and the "Traditional Chinese Medicine Law of the People's Republic of China," the National Medical Products Administration (NMPA), the Ministry of Agriculture and Rural Affairs, the National Forestry and Grassland Administration, and the National Administration of Traditional Chinese Medicine have jointly formulated the "Good Agricultural Practice for Chinese Herbal Medicines" (hereinafter referred to as "this Practice"). It is hereby released and implemented, with the following related matters announced:

I. This Practice applies to the management of the entire process of standardized production of Chinese herbal medicines by生产企业 (production enterprises) and constitutes the basic requirements for standardized production and management of Chinese herbal medicines. The Chinese herbal medicines referred to in this Practice are medicinal raw materials derived from medicinal plants, medicinal animals, and other resources, obtained through standardized planting (including ecological planting, wild tending, and imitative wild cultivation), breeding, harvesting, and field processing, and used for the production of TCM decoction pieces and TCM preparations.

The term "Chinese herbal medicine production enterprises" as used in this announcement includes planting, breeding, or cultivation cooperatives or associations with enterprise characteristics.

II. TCM decoction piece production enterprises and marketing authorization holders of TCM preparations are encouraged to establish or co-build, within the production areas of Chinese herbal medicines, production enterprises and bases that comply with this Practice, thereby extending the pharmaceutical quality management system to these production areas.

TCM production enterprises are encouraged to prioritize the use of Chinese herbal medicines that meet the requirements of this Practice. Where explicit requirements are stipulated in drug approval documents, TCM production enterprises must use Chinese herbal medicines that comply with this Practice. Relevant TCM production enterprises shall conduct supplier verification in accordance with the law, and conduct audits and inspections based on the requirements of this Practice to ensure compliance.

III. For TCM production enterprises using Chinese herbal medicines that meet the requirements of this Practice, they may, in accordance with relevant regulations on drug labeling, indicate "Herbal materials comply with GAP requirements" in an appropriate location on the drug label, and may publicize this fact legally. For compound TCM preparations, this indication may only be made if all prescription ingredients meet the requirements of this Practice.

Provincial drug regulatory authorities shall strengthen supervision and inspection. For TCM production enterprises that are required to use, or indicate the use of, Chinese herbal medicines meeting this Practice, they shall, when necessary, conduct extended inspections of the corresponding Chinese herbal medicine production enterprises, focusing on whether they comply with this Practice. If non-compliance is found, they shall investigate and impose penalties in accordance with the law, order the TCM production enterprise to rectify within a specified period or remove the indication, and publicly disclose the corresponding Chinese herbal medicine production enterprises and their herbal varieties, notifying the people's government of the place of origin.

IV. Under the leadership of the provincial party committee and provincial government, relevant provincial administrative departments shall cooperate with and assist the people's governments in the production areas of Chinese herbal medicines in advancing the standardized development of Chinese herbal medicines. This includes improving the working mechanism for the high-quality development of the Chinese herbal medicine industry; formulating development plans for the Chinese herbal medicine industry; refining incentive policies to promote standardized development; establishing ledgers and credit files for Chinese herbal medicine production enterprises and their bases, implementing dynamic supervision; and establishing an information platform for traceability of standardized Chinese herbal medicine production. Provinces with a strong foundation in standardized and intensive production of Chinese herbal medicines are encouraged to develop detailed implementation rules based on local conditions, actively explore implementation strategies, and accumulate experience for the broader promotion of this Practice.

V. Relevant provincial administrative departments shall, based on their respective responsibilities, conduct inspections and provide technical guidance for the implementation and promotion of this Practice. Agricultural and rural affairs departments shall take the lead in guiding the provision of seeds, seedlings, and germplasm resources, field management, the use of pesticides and fertilizers, and pest and disease control. Forestry and grassland departments shall take the lead in guiding ecological planting, wild tending, and imitative wild cultivation of Chinese herbal medicines, as well as the cultivation and breeding of Chinese herbal medicines under threatened species management. Traditional Chinese medicine administration departments shall collaborate in guiding the selection of seeds and seedlings, standardized planting, harvesting and processing, and ecological planting. Drug regulatory authorities shall conduct extended inspections of relevant Chinese herbal medicine production enterprises and provide guidance on medicinal requirements, field processing, and quality testing.

VI. Relevant provincial administrative departments shall strengthen collaboration and form a cohesive force to jointly promote the standardized, systematic, and intensive development of Chinese herbal medicines. They shall strengthen publicity and training according to their responsibilities to facilitate the implementation of this Practice. Daily supervision during implementation shall be strengthened. If significant problems are discovered or important recommendations for policy improvement exist, they shall be promptly reported to the corresponding national administrative departments.

This announcement is hereby made.

Annex: Good Agricultural Practice for Chinese Herbal Medicines

National Medical Products Administration Ministry of Agriculture and Rural Affairs National Forestry and Grassland Administration National Administration of Traditional Chinese Medicine

March 1, 2022