我国药品注册优先审评制度的进展与相关考量

摘要

This article describes the development and establishment process of drug priority review system in China.The overall conditions of the application,inclusion and review of drugs for priority review since the implement of this system are summarized.The feature of priority review system of China is analyzed in comparison with that of FDA.At last,the thoughts about how to further improve the priority review system and establish normal priority review mechanism under routine review system after solving the problem of review backlog,based on the goal of system reform of drug review and approval.%本文梳理了我国药品注册优先审评制度的演变与确立过程,介绍了自优先审评制度实施以来我国优先审评品种的申请、纳入与审评情况,分析了我国优先审评的特点及与美国FDA优先审评制度的不同.最后,结合我国药品审评审批制度改革目标,对解决药品审评积压任务后,如何进一步完善优先审评制度,建立常态审评下的药品优先审评常态机制进行了思考.