中国食品药品监管Issue(8)：18-25,8.DOI:10.3969/j.issn.1673-5390.2025.08.003
我国药品上市后备案类变更管理实践与展望
Management Practices and Prospects for Post-Approval Filing Changes of Drugs in China
周梦蝶 1李苏菊 1邸云瑞 1杨昊 1张帆 1许真玉1
作者信息
摘要
Abstract
Post-approval change management is a pivotal element of the pharmaceutical regulatory framework,with its principles and practices evolving alongside the pharmaceutical industry and the refinement of regulatory objectives.In 2021,the National Medical Products Administration(NMPA)issued the Provisions for Post-approval Changes of Drugs(Interim),establishing China's first standardized regulatory framework for managing changes to approved drugs.At its core,the system adopts a risk-based classification approach to ensure that changes of varying significance are appropriately regulated while safeguarding drug safety,efficacy,and quality control.For medium-risk changes that meet relevant technical guidelines,filing-based management may be applied.As an important part of the post-approval change management system,the design of the filing-based change mechanism reflects both scientific rigor and regulatory flexibility.Built on the current status of China's pharmaceutical industry and incorporating international best practices,the system enhances operational feasibility while allowing room for future refinement.This paper examines the evolution,current status,and challenges of China's filing-based change system for post-approval drug management,proposing recommendations to optimize regulatory frameworks and improve administrative efficiency.These insights aim to contribute to the high-quality development of China's pharmaceutical industry.关键词
药品上市后变更/备案类变更/监管体系/变更管理/备案管理Key words
post-approval changes/filing-based changes/regulatory framework/change management/filing management分类
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周梦蝶,李苏菊,邸云瑞,杨昊,张帆,许真玉..我国药品上市后备案类变更管理实践与展望[J].中国食品药品监管,2025,(8):18-25,8.
