Evaluation on good review practice in the United States of America and its implications for China
10.3969/j.issn.1674-2982.2015.02.010
- VernacularTitle:美国药品审评质量管理规范评介及对我国的启示
- Author:
Xiaoya GENG
;
Rong SHAO
- Publication Type:Journal Article
- Keywords:
The United States of America;
Drug evaluation;
Good review practice
- From:
Chinese Journal of Health Policy
2015;(2):60-65
- CountryChina
- Language:Chinese
-
Abstract:
The paper summarizes the background, development history and current state of good review prac-tice ( GRP) in the United States of America. On this basis, the paper then focuses on measures for the realization of GRP policy objective and introduces the effects of GRP by using the statistical data of the median time to application approval and approval rates of New drug applications( NDAs) and Biological License Applications( BLAs) on the first cycle. Through research, the paper considers a set of scientific and comprehensive GRP that can effectively guarantee the quality of drug reviews and improve the efficiency of drug reviews. However, China’s GRP is not complete yet. So it also suggests that improving GRP in China further by detailing the timeline of drug review in China, developing workable review templates, emphasizing training and the continuous improvement of GRP.
