对如何解决我国药品注册申请大量积压问题的探讨

摘要

药品审评审批积压已成为本行业一大难题,如何解决此问题,是目前各级食品药品监督管理总局与药品审评中心不得不面对的困境.本文借作者从业17年经验和曾在日本国家药品检验所学习心得进行探讨我国药品注册申请大量积压问题,希冀能为该问题的彻底解决抛砖引玉、建言献策.%The approval of drug review and approval has become a big problem in the industry. How to solve this problem is the dilemma of the current food and drug administration and drug review center. The authors with 17 years of working experiences and learning experience in Japan's National Institute for drug control, aims to explore the problem of China's drug registration application backlog, hoping for solve the problems throughly and provide valuable suggestions.