我国药品上市后变更管理实施情况及监管思考OA

It has been five years since the issuance and implementation of China's first regulatory document specifically addressing post-approval changes for drugs,the Administrative Measures for Post-approval Changes for Drugs(Interim).This article systematically reviews the regulatory framework and overall landscape of post-approval change management for drugs both in China and internationally during this period,with a focus on the major achievements in managing post-approval changes for marketed drugs in China.It further examines the problems and challenges encountered during the implementation of the Measures from the perspectives of both marketing authorization holders(MAHs)and regulatory authorities.Based on this analysis,considerations are given to strengthening the primary responsibility of MAHs in change management and to enhancing regulatory efficiency through innovative regulatory approaches.This study aims to provide insights for improving China's post-approval change management system.