Considerations on the chemistry, manufacture and control requirements for conditional marketing authorization drugs in China
10.11665/j.issn.1000-5048.20210518
- VernacularTitle:对我国附条件批准上市化药药学技术要求的思考
- Author:
Yifei ZHAO
1
;
Xin GENG
;
Lihua XU
;
Ting OU
;
Ning ZHANG
Author Information
1. 国家药品监督管理局药品审评中心
- Publication Type:Journal Article
- Keywords:
chemical drugs;
conditional marketing authorization;
pharmacy;
technological requirements
- From:
Journal of China Pharmaceutical University
2021;52(5):636-642
- CountryChina
- Language:Chinese
-
Abstract:
Drug Administration Law revised in 2019 proposed for the first time conditional marketing authorization at the legal level, marking the formal implementation of the conditional marketing authorization in China. This paper compares the regulations and technical requirements of conditional marketing authorization drugs in China with those in Europe and the United States, in an attempt to learn from the experience of chemistry, manufacture and control review of these drugs in Europe and the United States, and to discuss the pharmaceutical technical requirements of conditional marketing authorization drugs in China.
