Chinese Journal of Pharmacovigilance ›› 2013, Vol. 10 ›› Issue (3): 140-134.

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FDA's Risk Evaluation and Mitigation Strategy and the Inspirations to Our Country

ZHAO Pin ,BIAN Lei ,YANG Yue   

  1. College of Business Administration, Shenyang Pharmaceutical University, Liaoning Shenyang 110016, China
  • Received:2013-01-21 Revised:2016-03-09 Online:2013-03-08 Published:2016-03-09

Abstract: This article makes an introduction of the FDA's Risk Evaluation and Mitigation Strategy and analyses the background, legal framework, content, regulations and implementation process. It emphasizes the problems encountered in the implementation and relevant solutions and actions. It reflects thoughts and characteristics of FDA's policy-making to provide suggestions and references for domestic pharmacovigilance.

Key words: REMS, FDAAA, RiskMAPs