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 medicinal materials, strengthen the quality
control of traditional Chinese medicinal materials, and promote the high-quality
development of traditional Chinese medicine, according to the "Medicine
Administration Law of the People's Republic of China" The National Medical
Products Administration, the Ministry of Agriculture and Rural Affairs, the
National Forestry and Grass 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 and
implemented, and relevant matters will be announced. as follows:
1. This standard is applicable to the whole-process management of Chinese
medicinal materials production enterprises to standardize the production of
traditional Chinese medicinal materials, and is the basic requirement for the
standardized production and management of traditional Chinese medicinal
materials. 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 .
Encourage traditional Chinese medicine production enterprises 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. When using traditional Chinese medicinal materials that meet the
requirements of this specification, relevant traditional Chinese medicine
manufacturers can refer to the relevant regulations on drug label management,
and mark "the medicinal materials meet the GAP requirements" in the appropriate
position of the drug label, and can publicize them according to 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
corresponding Chinese herbal medicine manufacturers if necessary, focusing on
whether they comply with this standard, for traditional Chinese medicine
manufacturers that should use or label the use of traditional Chinese medicinal
materials that comply with this specification. If it is found to be
inconsistent, it shall be strictly investigated and punished according to law,
and the Chinese medicine manufacturer shall be ordered to make corrections
within a time limit, cancel the labeling, etc., and disclose the corresponding
Chinese herbal medicine manufacturer and its varieties, and notify the people's
government of the place where the Chinese herbal medicine 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 in 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 and form a joint force to 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 any major problems or major policy
improvement suggestions are found, please report to the corresponding state
management department in a timely manner.
Special announcement.
Attachment: Standard for quality management of production of 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