The production quality management standard of traditional Chinese medicine was officially released and implemented

2022-03-18

According to the official website of the State Food and drug administration, the production quality management norms of traditional Chinese medicine (hereinafter referred to as the norms) studied and formulated by the State Food and drug administration, the Ministry of agriculture and rural areas, the State Forestry and herbal administration and the State Administration of traditional Chinese medicine have been officially released and implemented. The Chinese medicinal materials referred to in the specification refer to the medicinal raw materials derived from medicinal plants, medicinal animals and other resources, which are used for the production of traditional Chinese medicine decoction pieces and traditional Chinese medicine preparations after standardized planting (including ecological planting, wild tending and imitation wild cultivation), breeding, harvesting and processing in the origin. The code proposes to encourage Chinese herbal medicine manufacturers such as Chinese herbal medicine slice manufacturers and Chinese patent medicine listing license holders to build and jointly build Chinese herbal medicine production enterprises and production bases that meet the code in the origin of Chinese herbal medicine, and extend the drug quality management system to the origin of Chinese herbal medicine. Traditional Chinese medicine manufacturers are encouraged to give priority to the use of traditional Chinese medicine that meets the requirements of this specification. If there are clear requirements in the drug approval certificate, the traditional Chinese medicine production enterprise shall use the traditional Chinese medicine that meets the requirements of these specifications in accordance with the regulations. Relevant traditional Chinese medicine manufacturers shall carry out supplier audit according to law and conduct audit and inspection in accordance with the requirements of this specification to ensure compliance with the requirements. In addition, for the use of traditional Chinese medicine that meets the requirements of this specification, relevant traditional Chinese medicine manufacturers can refer to the relevant provisions on drug label management and mark "medicinal materials meet the gap requirements" at an appropriate position in the drug label, which can be publicized according to law. For traditional Chinese medicine compound preparations, all prescription components can be labeled only if they meet the requirements of this specification. The provincial drug regulatory department shall strengthen supervision and inspection, and carry out extended inspection on the corresponding traditional Chinese medicine production enterprises that should use or mark the use of traditional Chinese medicine in accordance with these specifications when necessary, focusing on whether they comply with these specifications. If any nonconformity is found, it shall be severely investigated and punished according to law, and the traditional Chinese medicine production enterprises shall be ordered to make corrections within a time limit and cancel the labeling, etc., and the corresponding traditional Chinese medicine production enterprises and varieties of traditional Chinese medicine shall be made public, and the people's government of the place of origin of traditional Chinese medicine shall be notified. (outlook new era)

Edit:Yuanqi Tang    Responsible editor:Xiao Yu

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