摘要：通过研究美国百年来逐渐构建和丰富的药品注册管理法规体系特点，比较分析我国现行药品注册管理法规体系的特点，探索并提出我国药品注册管理法规体系需要完善的方面。

    关键词：药品注册；法规体系；比较

    中图分类号：R951文献标识码：A文章编号：1672-979X-(2009)01-0001-04

    Comparative Study on Chinese and American Procedures of Drug Registration

    YANG Zhi-min, DU Xiao-xi*

    (Center for Drug Evaluation of SFDA, Beijing 100038, China)

    Abstract：Through the research on the characteristics of American procedures of drug registration which are consummated gradually for hundreds of years, this paper compares and analyzes the different characteristics of Chinese procedures of drug registration, and provides the aspects of improvement.

    Key words：drug registration; procedures; comparison

    历史上曾发生过多起由于药品审批管理不严而造成严重不良反应的恶性事件 ......