The four departments issued the announcement of the "Quality Management Specification for the Production of Chinese Medicinal Materials"

On March 17, 2022, the State Food and Drug Administration, the Ministry of Agriculture and Rural Affairs, the State Forestry and Grassland Administration, and the State Administration of Traditional Chinese Medicine issued an announcement on the "Quality Management Practice for Chinese Medicinal Materials"
.
The original text is as follows: In order 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", promote the standardized production of traditional Chinese medicine materials, strengthen the quality control of traditional Chinese medicine materials, and promote the high-quality development of traditional Chinese medicine, according to the "Pharmaceutical Administration Law of the People's Republic of China" and "China The Law of the People's Republic of China on Traditional Chinese Medicine, the State Food and Drug Administration, the Ministry of Agriculture and Rural Affairs, the State Forestry and Grassland Administration, and the State Administration of Traditional Chinese Medicine have researched and formulated the "Quality Management Specification for the Production of Chinese Medicinal Materials" (hereinafter referred to as the Specification), which are hereby promulgated for implementation, and will be Relevant matters are announced as follows: 1.
This standard applies to the whole-process management of Chinese herbal medicine production enterprises to standardize the production of Chinese herbal medicines, and is the basic requirement for the standardized production and management of Chinese herbal medicines
.
The traditional Chinese medicinal materials involved in this specification refer to medicinal plants, medicinal animals and other resources, which are used in the production of traditional Chinese medicines after standardized planting (including ecological planting, wild tending and imitation wild cultivation), breeding, harvesting and processing at the place of origin.
Medicinal raw materials for decoction pieces and traditional Chinese medicine preparations
.
The Chinese herbal medicine production enterprises referred to in this announcement include professional planting and breeding cooperatives or associations with an enterprise nature
.
2.
Encourage Chinese herbal medicine manufacturers such as Chinese herbal decoction pieces manufacturers and Chinese patent medicine marketing license holders to establish their own and jointly build Chinese herbal medicine production enterprises and production bases that comply with this standard in the production areas of Chinese herbal medicines, and extend the drug quality management system to the production areas of Chinese herbal medicines
.
Manufacturers of traditional Chinese medicines are encouraged to give priority to the use of traditional Chinese medicinal materials that meet the requirements of this specification
.
If there are clear requirements in the drug approval documents, etc.
, the traditional Chinese medicine manufacturer shall use the traditional Chinese medicinal materials that meet the requirements of this specification in accordance with the regulations
.
Relevant traditional Chinese medicine manufacturers shall conduct supplier audits in accordance with the law, conduct audits and inspections in accordance with the requirements of this specification, and ensure compliance with the requirements
.
3.
To use Chinese herbal medicines that meet the requirements of this specification, relevant Chinese medicine manufacturers can refer to the relevant regulations on drug label management, and mark "the herbs meet the GAP requirements" in the appropriate position of the drug label, which can be publicized in accordance with the law
.
For traditional Chinese medicine compound preparations, all prescription ingredients must meet the requirements of this specification before they can be labeled
.
Provincial-level drug supervision and administration departments shall strengthen supervision and inspection, and conduct extended inspections of the corresponding Chinese herbal medicine manufacturers if necessary for the production enterprises of traditional Chinese medicines that should use or label the use of Chinese herbal medicines in accordance with this specification, focusing on whether they comply with this specification
.
If it is found to be inconsistent, it shall be strictly investigated and punished in accordance with the law, and the traditional Chinese medicine manufacturer shall be ordered to make corrections within a time limit, cancel the labeling, etc.
, and disclose the corresponding traditional Chinese medicinal material manufacturer and its varieties, and notify the people's government of the place where the traditional Chinese medicinal material is produced
.
4.
Under the leadership of the provincial party committee and the provincial government, the relevant administrative departments of each province shall cooperate and assist the people's government of the origin of Chinese medicinal materials to do a good job in the standardized development of Chinese medicinal materials, such as improving the working mechanism for the high-quality development of the Chinese medicinal materials industry; formulating the development plan of the Chinese medicinal materials industry; Promote incentive policies for the standardized development of Chinese medicinal materials; establish ledgers and credit files for Chinese medicinal materials production enterprises and their production bases, and implement dynamic supervision; establish an information platform for the standardized production and traceability of traditional Chinese medicinal materials
.
Provinces with a good foundation for standardized and intensive production of traditional Chinese medicinal materials are encouraged to study and formulate detailed implementation rules based on the actual development of traditional Chinese medicinal materials in their jurisdictions, actively explore and advance, and accumulate experience in the in-depth promotion of this standard
.
5.
Relevant administrative departments of each province shall inspect and provide technical guidance on the implementation and promotion of this Code in accordance with their duties
.
The agricultural and rural departments take the lead in providing guidance on the provision of Chinese herbal medicine seeds, seedlings and provenance, field management, pesticide and fertilizer use, and pest control
.
The forestry and grassland departments take the lead in providing guidance on the ecological planting, wild tending, and imitation wild cultivation of traditional Chinese medicinal materials, as well as the planting and breeding of traditional Chinese medicinal materials that fall under the category of endangered management
.
The traditional Chinese medicine management department shall coordinately provide guidance on seedlings, standardized planting, harvesting and processing, and ecological planting of traditional Chinese medicinal materials
.
The drug supervision and management department shall carry out extended inspections on corresponding Chinese herbal medicine production enterprises, and provide guidance on medicinal requirements, origin processing, and quality inspection
.
6.
Relevant management departments of all provinces should strengthen cooperation, form a joint force, jointly promote the standardized, standardized and intensive development of traditional Chinese medicinal materials, strengthen publicity and training according to their responsibilities, and promote the implementation of this standard
.
Strengthen daily supervision during implementation.
If you find major problems or have major policy improvement suggestions, please report to the corresponding state management department in a timely manner
.
Hereby announce
.
Attachment: Good Manufacturing Practice for Chinese Medicinal Materials State Food and Drug Administration, Ministry of Agriculture and Rural Affairs, State Forestry and Grass Administration, State Administration of Traditional Chinese Medicine March 1, 2022