药品上市后变更管理现状及思考

doi:10.19803/j.1672-8629.20250488

摘要/Abstract

摘要： 目的分析国内外药品上市后变更管理现状,为我国药品上市后变更研究及管理提供参考。方法对比分析美国、欧洲、中国的药品上市后变更制度及国际人用药品注册技术协调会（ICH）《Q12：药品生命周期管理的技术和监管考虑》相关内容,并结合国内监管要求和行业实际进行思考。结果我国药品变更管理框架基本完善,但由于上市后变更情形的复杂性,上市后变更监管存在多个主体、各省行业水平存在差异等问题,我国上市后变更研究及管理工作可进一步完善。结论建议各级药监部门和产业界通力协作,通过加强药品的全生命周期管理、统一各级药监部门的变更管理标准、加强药品上市许可持有人的变更管理能力等措施,共同促进我国药品上市后变更管理工作水平的提升。

关键词: 药品上市后变更, ICH Q12, 风险监管理念, 药品全生命周期, 药品上市许可持有人

Abstract: Objective To analyze the current regulation of post-approval changes to pharmaceutical products both at home and abroad so as to provide references for the research on and regulation of post-approval changes in China. Methods The systems for post-approval changes to drugs in the United States, Europe, and China and the provisions of ICH Q12 were compared and analyzed. Domestic regulatory requirements and industrial practices were taken into consideration. Results China's framework for regulation of post-approval changes was basically full-fledged. However，due to the complexity of variations, multiple regulatory bodies in China, and disparities in the development of the pharmaceutical industry between provinces, there was still room for improvement in this field. Conclusion Regulators of drugs and manufacturers should collaborate closely to keep upgrading the management system for post-marketing changes by strengthening the lifecycle mana-gement of drugs, adopting the same standards, and enhancing the management capabilities of marketing authorization holders.

Key words: Post-Approval Changes to Pharmaceutical Products, ICH Q12, Risk Supervision, Lifecycle Management of Drugs, Marketing Authorization Holders

中图分类号:

R951
R994.11

范乙, 陈爱萍, 杨华, 周瑞琪. 药品上市后变更管理现状及思考[J]. 中国药物警戒, 2025, 22(12): 1370-1375.

FAN Yi, CHEN Aiping, YANG Hua, ZHOU Ruiqi. Current Regulation of Post-Approval Changes to Pharmaceutical Products[J]. Chinese Journal of Pharmacovigilance, 2025, 22(12): 1370-1375.

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https://zgywjj.magtechjournal.com/CN/Y2025/V22/I12/1370

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