欧美药品上市后安全性监测体系发展趋势分析及其启示

Development trends of the post-marketing drug safety surveillance systems in EU and US

近年来,欧盟和美国对于监测上市后药品的安全性愈加重视,在加强各自的药品上市后安全性监测体系方面采取了不少新举措。本文分析了欧美药品上市后安全性监测体系的发展趋势,并探讨了对于我国的借鉴意义。

In recent years EU and US have paid more attention to the post-marketing surveillance of drug safety. New measures have been taken to strengthen the post-marketing drug safety surveillance systems. This article analyzes the development trends of the post-marketing drug safety surveillance systems in EU and US,and discusses its reference significance to China.