风险管理是当今全球药品监管最热门的话题,药品风险管理为在药品生命周期内,用于优化药品的效益/风险比的一个反复持续的管理过程。美国是最早将风险管理引入药品监管的国家,并在风险管理上做出大量的创新,积攒了丰富的经验。本文对美国风险管理发展历程及相关文件进行了简要介绍,着重探讨了药品上市后风险管理的方法,旨在促进风险管理在我国药品监管中的全面发展。 Risk management is the hottest topic in drug regulation around the world today, and drug risk management is an iterative management process used to optimize the benefit / risk ratio of medicines over the life of the drug. The United States is the first country that introduced risk management into drug regulation and has made a lot of innovations in risk management and accumulated rich experience. This article gives a brief introduction of the history of risk management in the United States and related documents, and focuses on the risk management methods after the listing of pharmaceuticals, in order to promote the all-round development of risk management in China’s drug regulation.