我国药品注册行政受理的发展历程及实施现状

The development history and current implementation status of drug registration administrative acceptance in China

介绍我国药品注册审批体系的启动环节——行政受理的发展历程,并从机构设置、法规依据、管理模式等方面分析当前的实施现状。利用文献综述的方法进行回顾性分析。我国药品注册行政受理已经具备了一定的科学性和系统性,也显示出了系统运转的可靠性,但与服务型政府的整体要求相比,尚存在着差距,有待改进。

The aim of the article is to introduce the development history of administrative acceptance, the start link of drug registration approval system, analyze the current implementation status from the organization setup, legal and regulations basis, management mode and so on. Retrospective analysis was carried out using the method of literature review. Drug registration administrative acceptance in China has already had certain scientific nature and systematicness, also it shows the reliability of the system operation. However, compared with the overall requirements of service-oriented government, there still have some gaps to be improved.