立足监管——关注中药上市后安全  

Focus on post-marketing safety of traditional Chinese medicine from perspective of supervision

作　　者：张燕芬 张宇宾 王新敏[3] 于丹丹[3] ZHANG Yanfen;ZHANG Yubin;WANG Xinmin;YU Dandan(Nanjing Institute for Food and Drug Supervision and Inspection/Nanjing Drug(Medical device)Adverse Reaction Monitoring Center,Nanjing 211198,China;Nanjing Market Supervision Administration,Nanjing 210007,China;Jiangsu Adverse Drug Reaction Monitoring Center,Nanjing 210002,China)

机构地区：[1]南京市食品药品监督检验院/南京市药品(医疗器械)不良反应监测中心,江苏南京211198 [2]南京市市场监督管理局,江苏南京210007 [3]江苏省药品不良反应监测中心,江苏南京210002

出　　处：《药物评价研究》2024年第11期2449-2458,共10页Drug Evaluation Research

基　　金：南京市市场监督管理局2022年度重点科技项目(Kj2022049)。

摘　　要：通过对中药上市后安全监管的研究,为科学挖掘中药医学价值、降低使用风险提供监管支持。以短语检索法查阅并研究分析国家监管部门发布实施的中药监管相关规范性文件和公示信息,对中药上市后安全监管现状进行归纳总结,为立足监管关注中药上市后安全提出见解。2013—2023年我国制定的《中药注册管理专门规定》等8部规范性文件中涵盖中药上市后安全监管相关内容,但未结合其特性建立专属性高的中药上市后安全监管制度体系;近10年的中药说明书安全性信息修订公告均由国家药品监督管理局发布;中药不良反应报告占比为13%,企业自主报告力度不够;古代经典名方中药复方制剂的安全性信息需持续完善。应认识到关注中药上市后安全的现实意义,从构建制度体系、建立联动机制、体现中药特性和强化责任落实等方面推动中药上市后安全监管。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.

关 键 词：中药 上市后安全 监管 不良反应 古代经典名方 

分 类 号：R95[医药卫生—药学]