省级药监机构视角下药品上市后变更管理研究  

Research on the Management of Post-marketing Drug Change from the Perspective of Province-level Regulatory Agencies

作　　者：陈超 张景辰 陈桂良 Chen Chao;Zhang Jingchen;Chen Guiliang(Shanghai Center for Drug Evaluation and Inspection,Shanghai 201203,China)

机构地区：[1]上海药品审评核查中心,上海201203

出　　处：《中国药事》2021年第8期856-861,共6页Chinese Pharmaceutical Affairs

基　　金：国家药典委员会标准提高项目:药品质量风险及药品全生命周期管理指导原则建立研究(编号2008Y001)。

摘　　要：目的:为省级药品监管机构建立和完善药品上市后变更监管体系提供建议。方法:分析美国和欧盟对药品上市后变更的管理模式、国内药品上市后变更新的法规要求和省级药品监督管理机构所面临的现实情况,进行思考和总结。结果:虽然欧美和我国对药品上市后变更都是采取基于风险的分类管理,但具体实施上还是存在较大差异。经验虽可借鉴,但更需要结合自身实际,探索省级监管机构的监管策略。结论:省级监管机构为建立和完善药品上市后变更监管体系,应建立完善的工作机制、加强审评核查能力建设和促进落实持有人主体责任。Objective:To put forward some suggestions for province-level regulators on establishing and improving their supervision system for post-marketing drug change in China.Method:Through the analysis of changes in management modes after being listed in USA and EU,the new regulatory requirements of post-marketing drug change in China and the practical situation faced by provincial drug supervision and administration organizations were studied and summarized.Results:USA,EU and China adopt riskbased sort management for post-marketing drug change,but there are still intense differences in the specific implementation.Although the experience could be used for references,province-level regulators need to explore the specific supervision strategies based on their own reality.Conclusion:The province-level regulators are supposed to establish a sound working mechanism,strengthen the construction of evaluation and inspection ability and promote the implementation of the main responsibility of the holder in order to establish and improve a post-marketing drug change supervision system.

关 键 词：药品上市后变更 省级药品监管机构 药品监管科学 监管策略 监管体系 

分 类 号：R95[医药卫生—药学]