中国药物警戒 ›› 2019, Vol. 16 ›› Issue (11): 666-669.
DOI: 10.19803/j.1672-8629.2019.11.05

• 药品上市许可持有人制度专栏 • 上一篇    下一篇

药品上市许可持有人在药品全生命周期中安全风险主体责任的探讨

钟露苗   

  1. 湖南省药品审评认证与不良反应监测中心,湖南 长沙410013
  • 收稿日期:2019-11-27 修回日期:2019-11-27 出版日期:2019-11-20 发布日期:2019-11-27
  • 作者简介:钟露苗,女,博士,主任药师,药械不良反应/事件监测。

MAHs’ Principal Responsibilities for Safety Risk during the Whole-life Cycle of Drugs

ZHONG Lumiao   

  1. Hunan Center for Drug Evaluation and Authentication and ADR Monitoring, Changsha Hunan 410013, China
  • Received:2019-11-27 Revised:2019-11-27 Online:2019-11-20 Published:2019-11-27

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摘要： 目的 促进我国药品上市许可持有人安全风险主体责任意识的提升。方法 通过分析上市前和上市后药品安全风险产生的原因,借鉴国外药品上市后的监管模式,助力提升我国药品上市许可持有人安全风险主体责任意识。结果与结论 在药品全生命周期中,药品上市许可持有人作为研发、生产和经济获益的主体,应该全面承担起药品安全风险的主体责任。

关键词: 药品上市许可持有人, 全生命周期, 药品安全风险, 主体责任

Abstract: Objective To enhance MAHs’awareness of principal responsibilities for drug safety risks.Methods The causes of pre-marketing and post-marketing risks were analyzed. The strengths of regulatory models overseas were summarized.Results & Conclusion In the whole-life cycle of drugs, MAHs, as the main body of research and development, production and economic benefit, should bear the principal responsibilities for drug safety risks.

Key words: MAHs, whole-life cycle, drug safety risk, principal responsibility

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