中国药物警戒 ›› 2013, Vol. 10 ›› Issue (5): 283-285.

• 政策与法规研究 • 上一篇    下一篇

美国药品风险评估与减低计划的简介与启示

李淑芳1,潘文灏2   

  1. 1.沈阳医学:奉天医:药剂科,辽宁沈阳 110024；
    2.辽宁中医药大学附属医:药剂科,辽宁沈阳 110032
  • 收稿日期:2012-11-15 修回日期:2016-03-09 出版日期:2013-05-08 发布日期:2016-03-09
  • 作者简介:李淑芳,女,副主任药师,医:药学。

The Introduction and Inspiration of Risk Evaluation and Mitigation Strategies in the Unite State

LI Shu -fang1, PAN Wen -hao2   

  1. 1.The Fengtian Hospital of Shenyang Medical University, Liaoning Shenyang 110024, China;
    2.The Affiliated Hospital of Liaoning University of Traditional Chinese Medicine, Liaoning Shenyang 110032, China
  • Received:2012-11-15 Revised:2016-03-09 Online:2013-05-08 Published:2016-03-09

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摘要： 目的 为发展我国药品风险减低的相关举措提供参考。方法 通过对美国药品风险评估与减低计划文献资料的查阅,对文献研究的方法进行研究。结果 美国药品风险评估与减低计划的发展已较完善,并逐步标准化、系统化。结论 美国药品风险评估与减低计划的运用及标准化措施可为我国药品风险减低相关举措的发展提供参考。

关键词: 美国食品药品监督管理局, 药品风险评估与减低计划, 标准化

Abstract: Objective To provide suggestions for drug risk evaluation and mitigation in China. Methods To study the material of Risk Evaluation and Mitigation Strategies(REMS) in US Food and Drug Administration(FDA) by literature. Results The development of FDA's REMS is more perfect, and will become standardized and systematized gradually. Conclusion The application of REMS and its standard measures are significant to the improvement of our Drug Risk Evaluation and Mitigation.

Key words: Food and Drug Administration(FDA), Risk Evaluation and Mitigation Strategies(REMS), standardization

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