Analysis of Historical Evolution and Current Situation of Approval System for Marketing Application of New Chemical Pharmaceuticals in China
- VernacularTitle:我国新药中化学药品生产批准上市申请审批制度历史演变与现状分析
- Author:
Xuan WANG
1
;
Jubo LIU
;
Wentao ZHU
Author Information
1. 亿帆医药研究院(北京)有限公司 北京100102
- Keywords:
New pharmaceuticals;
Marketing;
Approval system;
Evolution;
Current situation
- From:
China Pharmacist
2018;21(2):314-317
- CountryChina
- Language:Chinese
-
Abstract:
Objective:To review the historical evolution and current situation of approval system for marketing application of new chemical pharmaceuticals in China to provide reference for the establishment of more perfect approval system. Methods: Through clearing up the historical evolution of approval regulations for marketing application and combining with the current approval system,the development track of the regulatory system from the vulgar administration gradually transferring to the scientific management was ana-lyzed comprehensively. Results and Conclusion: The dividend of current approval system has appeared, meanwhile, the constantly improving process will lay the foundation for setting up the regulatory system conforming to the situation of China and in line with inter-national standards.
