药品注册管理创新激励制度研究

Overview on innovative incentive system of drug registration

本文综述了近来有关药品注册和药物创新的研究,深度挖掘出其中激励和阻碍药物创新的若干因素,并将其概括为新药的界定、药品注册分类、药品审批程序、技术审评、沟通交流和风险管控5个方面,得出综合考虑以上因素,进行进一步系统研究的必要性。

This article reviews the recent research on drug registration and drug innovation,deeply exploring a number of factors that are incentives and disincentives to drug innovation.We summed up as five aspects,which are new drugs defined,classification of drug registration,drug approval process,technical review,communication,and the risk management and control.The conclusion is that further systematically research with comprehensive consideration of the above factors is necessary.