Impact of Recent Changes in Domestic Policies and Regulations on the Development and Application of Ge-neric Drugs
- VernacularTitle:近期国内政策法规变动对仿制药研发和申报的影响
- Author:
Wei SHEN
;
Yanfen JIN
- Keywords:
Generic drugs;
Policies and regulations;
Record;
Consistency evaluation
- From:
China Pharmacist
2017;20(2):321-324
- CountryChina
- Language:Chinese
-
Abstract:
Objective:To explore the impact of recent changes in domestic policies and regulations on the development and appli-cation of generic drugs. Methods:Through the collation of the recent regulatory documents, the policy changes for generic drugs were analyzed, and the corresponding development proposals were provided. Results and Conclusion:According to the possible impact of current policy changes on generic drug development, the relative solutions are proposed with the aim to provide certain reference for ge-neric pharmaceutical R & D institutions.
