FDA风险评估与减低策略实施与借鉴的思考

摘要

ObjectiveTointroducetheFDA'sRiskEvaluationandMitigationStrategyanddevelopmentprocess, provide suggestions to conduct Risk Evaluation and Mitigation Strategies (REMS) in China. Methods The materials of REMS in US Food and Drug Administration (FDA) official website were researched, and the related literature were analyzed. Results Applicant ensures that the benefits of a drug outweigh the risks of the drug by developing REMS,and U.S publishes a series of regulation and guidance to ensure REMS implement.Conclusion REMS could give some references for risk control measures.%目的对美国药品风险评估和减低策略(REMS)制度的发展历程、内容及实施过程等进行系统分析和介绍,以期推进我国药品风险控制计划.方法查阅中外文献和美国FDA官网有关REMS政策与进展.结果药品上市申请人通过制定REMS来确保药品效益大于风险,同时美国制定一系列法律法规和指南促进REMS的有效实施.结论美国REMS制度可为我国药品风险控制计划提供参考.