Marketing License System of Drugs at Home and Abroad:A Comparative Study
- VernacularTitle:国内外药品上市许可制度比较及借鉴
- Author:
Guan WEI
- Publication Type:Journal Article
- Keywords:
Drug;
Marketing license;
Production license;
Technology transfer
- From:
China Pharmacy
2007;0(34):-
- CountryChina
- Language:Chinese
-
Abstract:
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.
