冯媛媛 杨悦

    [摘要] 药品审评的质量和效率关系着整个药品上市进程。本文以药品注册优先审评程序为主线，基于我国药品审评实践，借鉴美国优先审评模式的成功经验，对比我国和美国的具体程序设计，找出我国程序设计的缺陷和不足，提出完善我国药品注册优先审评程序的相关建议，为药品注册优先审评制度建设提供可行性参考。

    [关键词] 优先审评；药品注册；审评制度；程序设计

    [中图分类号] R95 [文献标识码] A [文章编号] 1673-7210(2018)04(c)-0172-05

    Design and study on priority review procedure of drug registration in China

    FENG Yuanyuan1，2 YANG Yue1

    1.School of Business Administrator， Shenyang Pharmaceutical University， Liaoning Province， Shenyang 110016， China； 2.People′s Medical Publishing House Co.， Ltd.， Beijing 100021， China

    [Abstract] The quality and effectiveness of drug review is associated with the total procedure of drugs. Based on the practice of drug review in China and lessons from the successful experience of priority review in the United States， this paper takes the priority review procedure of drug registration as the main line. The defects and shortcomings are found out by comparing the procedure design of China with the one of the United States. Furthermore， this paper puts forward related suggestions to improve the priority review procedure of drug registration in China ......