美国药品风险评估与减低计划的简介与启示

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

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。

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.