美国儿科药品审批政策概述

Introduction of the American Examination and Approval Policies for Pediatric Drugs

简要介绍美国儿科药品审批政策并进行深入分析,总结其成功经验,为建立适合我国的儿科药品审批政策提供参考。

This paper briefly introduced and analyzed the examination and approval policies of FDA for pediatric drugs. Their successful experiences were summarized and can be used as reference for the establishment of the policies adaptive to the situation of China for the examination and approval of pediatric drugs.