Development of drug priority review system in China and relevant consideration
GAO Lei
DI Yun-rui
HUANG Qing-zhu
Abstract：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.
Keywords：special approvalpriority reviewreform of drug review and approvalcommunication
Publication Date：2017-01-01
Online Publishing Date：2026-08-14(First online date of this platform, not the publication date of the document)
Pages：8( 2656-2663 )