中国药物警戒 ›› 2017, Vol. 14 ›› Issue (12): 742-745.

• 法规与管理研究 • 上一篇    下一篇

美国对上市药品的再评价与监管经验

吴桂芝,冯红云,范燕,董铎   

  1. 国家食品药品监督管理总局药品评价中心，北京 100045
  • 收稿日期:2016-06-14 修回日期:2018-01-19 出版日期:2017-12-20 发布日期:2018-01-19
  • 作者简介:吴桂芝，女，博士，主任药师，药品不良反应监测与评价。
  • 基金资助:
    国家科技重大专项（2017ZX09101001-001-003）：药品再评价政策法规及实施策略研究。

Evaluation of Post-marketing Drugs and Regulatory Experiences in US

WU Gui-zhi, FENG Hong-yun , FAN Yan, DONG Duo   

  1. Center for Drug Reevaluation, CFDA, Beijing 10045, China
  • Received:2016-06-14 Revised:2018-01-19 Online:2017-12-20 Published:2018-01-19

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摘要： 目的 介绍和分析美国对上市后药品的监管历史和再评价经验，为我国上市后再评价工作提供参考。方法 通过梳理美国在1960年代实施的药效研究实施项目（DESI），解析美国对目前上市的未经FDA批准的药品的监管措施及指南，探讨随着法规的更新及认知水平的提高，美国如何开展对上市后药品的再评价以及取得的监管经验。结果与结论 我国目前针对上市后药品的再评价工作可以借鉴美国的药效研究实施项目以及针对未经FDA批准药品的评价和监管经验。

关键词: 上市后药品, 评价, 监管, 美国

Abstract: Objective Through introducing and analyzing regulatory history and evaluation experiences for post-marketing drugs, to provide valuable reference to reevaluation of post-marketing drugs in China. Methods By introducing Drug Efficacy Study Implementation (DESI) which performed in 1960s in US, and interpreting Marketed Unapproved Drugs-Compliance Policy Guide, the evaluation of post-marketing drugs and regulatory experiences obtained in US has been discussed following the updates of regulations and the improvement of cognitive level. Results and Conclusion Experiences obtained from DESI and actions taken for marketed unapproved drugs by FDA in US could provide valuable reference to reevaluation of post-marketing drugs in China.

Key words: post-marketing drug, evaluation, regulation, United States

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