National Medical Products Administration GAP Expert Working Group was established.

CCTV News:On May 5th, WeChat official account, the "China Medicine News", issued a notice from the General Department of National Medical Products Administration on the establishment of a GAP expert working group on Chinese herbal medicines.

All provinces, autonomous regions, municipalities directly under the central government and the drug administration of Xinjiang Production and Construction Corps, and all relevant units:

According to the Notice of National Medical Products Administration on Printing and Distributing Several Measures to Further Strengthen the Scientific Supervision of Traditional Chinese Medicine and Promote the Inheritance, Innovation and Development of Traditional Chinese Medicine (No.1 [2023] of the State Drug Administration), in order to promote the standardized development of traditional Chinese medicine, promote the orderly implementation of GAP (hereinafter referred to as GAP), strengthen the quality control of traditional Chinese medicine, promote the construction of traceability system of traditional Chinese medicine, improve the quality of traditional Chinese medicine from the source, and further play the guiding and supporting role of technical experts in the industry, National Medical Products Administration decided to set up a GAP expert working group on traditional Chinese medicine.

First, the members of the expert group are composed of professionals engaged in the research, planting/breeding, harvesting and processing, quality control, quality evaluation and administration of Chinese herbal medicines. They are required to have high academic attainments and professional level, and in principle they are not over 60 years old.

Two, National Medical Products Administration is responsible for the selection, addition and replacement of members of the expert group, formulate and adjust the work responsibilities and work requirements of the expert group.

National Medical Products Administration Verification Center set up an expert group office, which is responsible for the daily work of the expert group. The members of the office are composed of relevant departments of National Medical Products Administration, relevant staff members of directly affiliated units such as the Central Inspection Institute, Pharmacopoeia Committee and Verification Center.

Three, the expert group consists of 1 leader and 3 deputy heads. The term of office of all members is five years, and the members of the expert group can be supplemented and adjusted according to the needs of work and the wishes of experts. See the annex for the list of members of the first phase expert group. The expert group leader is Huang Luqi, the executive deputy leader is Wei Jianhe, and the deputy leaders are Guo Lanping and Gao Tianbing.

IV. Following the principles of scientificity, legality, openness, impartiality and objectivity, the expert group provides technical support and decision-making suggestions for the quality and safety supervision of Chinese herbal medicine production, promotes the standardized development of Chinese herbal medicines and promotes the implementation of GAP in Chinese herbal medicines. The specific responsibilities are as follows:

(a) to provide support for National Medical Products Administration to study and formulate technical guidance documents such as technical guidelines, inspection procedures and inspection and evaluation standards to promote the implementation of GAP in Chinese herbal medicines, and directly participate in the drafting of relevant documents when necessary.

(two) to provide technical advice for National Medical Products Administration to study and improve the standardization, industrialization and moderate scale development of Chinese herbal medicines, and to strengthen the management policy of quality and safety supervision of Chinese herbal medicines.

(three) according to the arrangement of National Medical Products Administration, to participate in the supervision and inspection of the GAP conformity inspection and causal inspection of Chinese herbal medicines related to the extended inspection of Chinese herbal medicines.

(four) according to the arrangement of National Medical Products Administration, to provide technical guidance for promoting the implementation of GAP in Chinese herbal medicines throughout the country and promoting the standardized production of Chinese herbal medicines.

(five) according to the arrangement of National Medical Products Administration, to provide opinions on the major disputes that may exist in the implementation and inspection of GAP in Chinese herbal medicines.

(VI) Investigate, collect, summarize and analyze the problems and risks in the implementation, inspection and standardized production of Chinese herbal medicines, and put forward solutions to National Medical Products Administration.

(seven) other technical consulting work related to the quality management of standardized production of Chinese herbal medicines.

5. Members of the expert group shall attend meetings and GAP-related inspections of Chinese herbal medicines according to the arrangement of National Medical Products Administration; Provide specific and clear professional opinions and suggestions objectively, fairly and rigorously; Take the initiative to avoid related activities that I have an interest in; Not to participate in standardized production of Chinese herbal medicines, GAP implementation of Chinese herbal medicines and other related commercial activities in the name of members of the expert group; Undertake the obligation of confidentiality according to the law and regulations.

Six, members of the expert group have the right to independently and fully express their personal opinions and suggestions within the scope of performing their duties as members, receive corresponding labor remuneration in accordance with relevant regulations, and resign according to their own wishes.

Seven, the provincial drug regulatory authorities can be combined with the actual development of Chinese herbal medicines in their respective administrative areas, study and set up a GAP expert group of Chinese herbal medicines in their respective administrative areas, and guide and promote the standardized development of Chinese herbal medicines in their respective administrative areas.

Attachment: List of GAP Expert Working Groups of Chinese Herbal Medicine in National Medical Products Administration (Phase I)