我国《药品注册管理办法》修订工作及有关思考

Introduction and analysis on the amendment of Drug Registration Regulations in China

介绍我国《药品注册管理办法》的制修订历程以及当前修订工作的具体情况,阐述了笔者对当前修订工作的若干分析和思考。

This paper introduces the establishment and amendment of Drug Registration Regulations in China,and analyzes the current revision of regulations in detail.