美国药品风险管理指南与案例分析

目的 简介药品风险管理的概念和方法,并附实例说明.方法 利用文献资料采取综述的方法,介绍药品风险管理概念在美国、欧盟的发展和药品风险管理的内容.结果 药品的风险管理是一个运用多学科方法来记载、监控、评价和干预药品不良反应的科学系统方法.它适用于药品从前体化合物筛选、新药审批、上市后监控直至撤出市场的整个生命周期.结论 国际药品风险管理的经验对我国药品安全管理工作具有借鉴意义,我国在药品风险管理方面应逐步与国际接轨,提出符合我国国情的药品风险管理指导方案以进一步改善药品安全管理.

Risk Management Guidances and Case Studies for Drug Administration

The risk management for pharmaceutical products is a multidisciplinary method to document,monitor and evaluate ad- verse drug events(ADEs),and plan interventions.It applies to the life of a drug from Investigational New Drug(IND),New Drug Application(NDA),post-marketing,and even removal from mar- keting.In this article we reviewed the recently released FDA risk management guidances and used three cases to illustrate the con- cept and methods of the risk management.At the end we also briefly review the development of risk management in European and suggested China should review the risk management strategies and improve drug safety using some experiences from USA and European countries.