我国药品检查过程中上市后变更风险的研究与控制

Research and Control of Post-approval Change Risks in Drug Inspection Process in China

对药品变更管理的有关法规、指南进行总结,结合当前新形势下我国药品监管的新要求,分析研判我国药品检查面临的挑战。通过案例分析,采用风险管理理念指导药品检查过程中上市后变更的管理工作。本文结合近年来药品审评、检查过程中发现的问题,对药品上市后变更的检查思路、现状、存在的问题进行了分析。

Summarize the relevant laws,regulations and guidelines for drug change management,analyze and judge the challenges of new requirements in drug inspection under the current new situation of China.Through case analysis,the risk management concept is used to guide the management of post-approval changes in the drug inspection process.Based on the problems found in the drug review and inspection process in recent years,this article analyzes the inspection ideas,current status,and existing problems of post-approval changes.