我国药品上市后安全性信息变更的实施要点

Analysis of the key implementation points for changes in safety information of marketed drugs in China

药品上市后安全性信息变更是药品生命周期管理的重要组成部分。随着我国药品变更监管体系的逐步完善,上市后变更管理要求发生很大变化,其中安全性信息变更逐渐引发关注。药品上市许可持有人进行药品安全性信息变更时,应从变更的内容、风险程度、变更实施要求进行考量,根据变更内容对临床安全有效使用产生的影响程度和风险高低,评估确定变更分类;对重大变更、中等变更和微小变更事项分别按照相应变更程序进行补充申请、备案和报告。药品安全性信息变更后应加强临床沟通,以利于信息的有效传递。

Post-marketing changes in safety information are integral to the management of a drug's lifecycle.As China's regulatory system for drug changes gradually improves,there have been significant shifts in post-marketing change manage⁃ment requirements,particularly focusing on safety information changes,which have garnered increasing attention.When mar⁃keting authorization holders alter drug safety information,they should consider the nature of the change,the level of risk in⁃volved,and the implementation requirements.Changes are classified based on their impact and risk on clinical safety and ef⁃fective use,distinguishing between major,moderate,and minor changes.Supplementary applications,filings,or reports should be made according to the corresponding change procedures.Strengthening clinical communication post-change in drug safety information is essential for effective information transmission.