个例药品不良反应报告管理浅析与思考  

Management of individual adverse drug reaction reports

作　　者：里筱竹 王蔷 逄瑜 张轶菁 LI Xiaozhu;WANG Qiang;PANG Yu;ZHANG Yijing(BeiGene,Ltd.(BeiGene)c/o Beijing,Inc.,Beijing 100022,China;Bristol-Myers Squibb(China)Investment Co.,Ltd.,Shanghai 200240,China;RemeGen Co.,Ltd.,Beijing 100020,China)

机构地区：[1]百济神州(北京)生物科技有限公司,北京100022 [2]百时美施贵宝(中国)投资有限公司,上海200040 [3]荣昌生物制药(烟台)有限公司,北京100020

出　　处：《中国药物警戒》2023年第9期975-977,986,共4页Chinese Journal of Pharmacovigilance

摘　　要：目的 结合国内外药物警戒法规对个例药品不良反应报告(简称“个例报告”)管理工作各环节要点进行总结和梳理,为药品上市许可持有人(简称“持有人”)开展个例报告管理工作提供参考。方法 通过查阅相关文献及国内外法规,对个例报告管理各环节的操作流程进行全面介绍,结合实际经验讨论操作过程中个例报告管理工作需要关注的问题。结果与结论 个例报告是持有人开展药物警戒工作的基础,持有人应按照相关规定,合规开展个例报告的收集、处理及递交工作。Objective To summarize and analyze the key points of ways in which individual case safety reports(ICSRs)are managed by referring to domestic and overseas laws and regulations in order to assist marketing authorization holders(MAHs)in handling ICSRs.Methods Based on a review of related literature and regulations at home and abroad,the whole process of ICSR management was introduced.Speaking from experience,we discussed the problems that were worthy of attention in the course of ICSR management.Results and Conclusion ICSRs underline pharmacovigilance by MAHs,who should collect,process,and submit ICSRs in accordance with related laws and regulations.

关 键 词：药物警戒 药品上市许可持有人 药品不良反应 个例药品不良反应报告 安全性 药物警戒质量管理规范 

分 类 号：R954[医药卫生—药学]