浅谈美国食品和药品监督管理局对上市后研究的背景与内容及其启示

Background,contents and enlightenment to us of the postmarketing studies of Food and Drug Administration

美国食品和药品监督管理局对于上市后研究有较详细的规定。相比较而言,我国对于上市后研究的法规还比较薄弱,还有不少改进的空间。比如上市前和后的管理衔接,管理规范和指导原则方面。本文从背景、内容和具体实施步骤上对此进行分析和介绍以期对我国的上市后研究有所启示。

Food and Drug Administration has detailed regulations regarding to postmarketing studies.Comparably,it still has great space for improvement of the postmarketing studies in China.For example,the connection between pre and postmarketing regulations,rules and guidelines.The current article has introduced and analyzed the background,contents and specific implementation methods of it in order to enlighten the postmarketing studies in China.