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, and provides references for the construction of priority review system of drug registration.
冯媛媛1,2 杨悦1▲. 我国药品注册优先审评程序设计研究[J]. 中国医药导报, 2018, 15(12): 172-176.
FENG Yuanyuan1,2 YANG Yue1▲. Design and study on priority review procedure of drug registration in China. 中国医药导报, 2018, 15(12): 172-176.
2018, Vol. 15 
京公网安备 11010502046598号