Focus on post-marketing safety of traditional Chinese medicine from perspective of supervision
Through the research on the post-marketing safety regulation of traditional Chinese medicine,it can provide regulatory support for scientifically mining the medical value of traditional Chinese medicine and reducing the use risk.The phrase search method was used to consult and analyze the relevant normative documents and public information of traditional Chinese medicine supervision issued and implemented by the national regulatory authorities,and the current situation of the safety supervision of traditional Chinese medicine after marketing was summarized,so as to provide insights for focusing on the safety of traditional Chinese medicine after marketing based on supervision.From 2013 to 2023,eight normative documents,including the Special Regulations on the Registration and Management of Chinese Medicine,have covered the relevant contents of post-listing safety supervision of Chinese medicine,but a highly specialized post-listing safety supervision system of Chinese medicine has not been established according to its characteristics.In the past ten years,the announcement of the revision of the safety information of traditional Chinese medicine instructions was issued by the State Drug Administration,the proportion of adverse reactions reported by traditional Chinese medicine is about 13％,and the independent reporting of enterprises is insufficient,the safety information of classical Chinese medicine compound preparations needs to be continuously improved.We should realize the practical significance of paying attention to the post-marketing safety of traditional Chinese medicine,and promote the post-marketing safety supervision of traditional Chinese medicine from the aspects of building a system,establishing a linkage mechanism,reflecting the characteristics of traditional Chinese medicine,and strengthening the implementation of responsibility.
traditional Chinese medicinepost-market safetysupervisionadverse reactionclassical Chinese medicine compound preparations
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