摘要
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.
Abstract
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.
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