文献来源的上市后药品不良反应报告常见问题分析  

Common Problems with Post-marketing Adverse Drug Reaction Reports from Literature

作　　者：朱兰 朱彦[2] 刘丽红[2] 邵波 刘红亮 熊玮仪 ZHU Lan;ZHU Yan;LIU Lihong;SHAO Bo;LIU Hongliang;XIONG weiyi(Center for Drug Reevaluation,NMPA/NMPA Key Laboratory for Research and Evaluation of Pharmacovigilance,Beijing 100022,China;Institute of Information on Traditional Chinese Medicine,China Academy of Chinese Medical Sciences,Beijing 100022,China)

机构地区：[1]国家药品监督管理局药品评价中心,药物警戒研究与评价重点实验室,北京100022 [2]中国中医科学院中医药信息研究所,北京100027

出　　处：《中国药物警戒》2021年第12期1155-1158,共4页Chinese Journal of Pharmacovigilance

基　　金：国家重点研发计划课题(2018YFC1707409);中国中医科学院基本科研业务费自主选题项目(ZZ150314)。

摘　　要：目的总结我国文献来源的上市后个例药品不良反应报告常见问题,并提出相关建议,为药品上市许可持有人提供参考。方法列举文献来源的上市后个例药品不良反应报告中的常见实际问题,对照我国药品监管部门2018年来发布的相关文件和指导原则,以及人用药品注册技术要求国际协调会(ICH)E2D指导原则中对来文献来源的上市后个例药品不良反应报告相关要求,分析问题并提出改进建议。结果与结论部分文献来源的不良反应报告的规范性、完整性和及时性等有所欠缺,建议药品上市许可持有人加强相关工作以提高报告质量。Objective To summarize problems with post-marketing adverse drug reaction(ADR)reports collected from literature in China and give related advice to marketing authorization holders(MAHs).Methods The common problems with ADR reports from related literature were listed and analyzed.Suggestions for improvement were offered based on the requirements of relevant guidelines and documents issued by the NMPA after 2018 and the requirement of ICH E2 D guideline.Results and Conclusion The ADR reports collected from related literature are imperfect in terms of compliance,completeness and timeliness,and MAHs need to make more efforts to improve the quality of such reports.

关 键 词：药品不良反应 个例药品不良反应报告 文献检索 

分 类 号：R951[医药卫生—药学]