中国医院用药评价与分析2025，Vol.25Issue(8)：908-911,4.DOI:10.14009/j.issn.1672-2124.2025.08.002
中药上市后安全性评价数据分析方法指南
Guidelines for Data Analysis Methods of Safety Evaluation on Post-Marketing Traditional Chinese Medicine
摘要
Abstract
The post-marketing safety data of traditional Chinese medicine are characterized by diversity,abundance,and uneven quality.Full application of post-marketing data to elucidate the safety issues of traditional Chinese medicine,and promote the post-marketing safety evaluation of traditional Chinese medicine,is one of the critical component in promoting the inheritance and innovative development of traditional Chinese medicine.In 2024,Guidelines for Data Analysis Methods of Safety Evaluation on Post-Marketing Traditional Chinese Medicine(T/CACM 1622-2024)has been approved by the China Association of Chinese Medicine.This guideline starts from the scientific issue of data analysis methods for safety evaluation of post-marketing traditional Chinese medicine,deeply analyzes the characteristics of commonly used data analysis methods,and explains each analytical pathway in detail,clearly defining the respective application scopes and scenarios,so as to to provide robust technical support for institutions such as drug regulatory authorities,marketing authorization holders,medical institutions,universities,and research institutes in conducting data analysis for safety evaluation of post-marketing traditional Chinese medicine.关键词
上市中药/中药安全性评价/数据分析/指南/标准Key words
Post-marketing traditional Chinese medicine/Safety evaluation of traditional Chinese medicine/Data analysis/Guideline/Standard分类
医药卫生引用本文复制引用
张晓朦,孙鑫,荆志伟,李霞,蔡永铭,柴克燕,张俊华,吴嘉瑞..中药上市后安全性评价数据分析方法指南[J].中国医院用药评价与分析,2025,25(8):908-911,4.基金项目
国家中医药管理局高水平中医药重点学科建设项目-临床中药学(No.zyyzdxk-2023257) （No.zyyzdxk-2023257）
