国内外药品上市许可制度比较及借鉴

Marketing License System of Drugs at Home and Abroad:A Comparative Study

目的:为完善我国药品上市许可制度提供参考。方法:从药品注册分类、注册管理程序和药品上市许可与生产许可的结合等方面对国内外药品上市许可制度进行比较分析,并对我国实行药品上市许可人制度的必要性和可行性进行分析。结果与结论:我国目前实施的以药品批准文号为核心的上市许可制度,对药品法律责任的追究、药品监管模式、药品技术转让体系和药品委托生产等方面存在不利影响,应当进行改革。药品上市许可人制度目前在我国实行存在一定困难,但应当循序渐进,逐步确立该制度。

OBJECTIVE： To provide reference for the evolvement of the current drug marketing license system in China. METHODS： The registry classification, the drug registration procedure and the combination of marketing license and production license both at home and abroad were analyzed comparatively. In addition, the necessity and feasibility of the drug marketing license system in China were analyzed. RESULTS ＆ CONCLUSIONS： The current drug marketing license system that centered on license No. goes against the investigation of legal ability, drug administration mode, medicine technology transfer system and original equipment manufacture thus remains be reformed. There is still difficulty for the enforcement of drug marketing licensor system, yet it should be carried out step by step until its establishment.