摘要
随着我国药品行业的不断发展,各项法律法规也应运而生,自《药品上市后变更管理办法(试行)》实施以来,药品上市许可持有人进行相关的药学变更也变得更加规范化。本文从药品上市许可持有人进行已上市药品变更的角度出发,在遵守相关变更管理原则,建立完善的变更管理系统,科学合理确认变更管理类别,变更后回顾分析工作,重视质量体系类变更等方面进行探讨,以期对药品上市许可持有人进行变更管理工作提供一定的参考。
With the continuous development of the Chinese pharmaceutical industry,various laws and regulations have emerged.Since the implementation of the“Measures for The Management of Changes after Drugs are Put on the Market(Trial)”,the pharmaceutical changes related to marketing authorization holder have become more standardized.From the perspective of post-approval change,this paper discusses the following aspects,complying with the relevant change management principles,establishing a sophisticated change management system,scientifically and reasonably confirming the change management category,the review and analysis after the change,and paying attention to the quality system change,so as to provide some reference for the change management of marketing authorization holder.
作者
吴仁德
谢春菲
金狮
梁国嫔
WU Rende;XIE Chunfei;JIN Shi;LIANG Guopin(Jiangxi Drug Inspection Center,Nanchang Jiangxi 330000,China)
出处
《药品评价》
CAS
2022年第11期641-644,共4页
Drug Evaluation
基金
江西省药品监督管理局科研项目(2021KY36)。
关键词
药品上市许可持有人
变更管理系统
风险评估
变更管理类别
Marketing authorization holder
Change management system
Risk assessment
Change management category
