Chinese Journal of Pharmacovigilance ›› 2013, Vol. 10 ›› Issue (5): 283-285.

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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

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

CLC Number: