Status quo and improvement countermeasures of the priority review system for encouraged generic drug in China
- VernacularTitle:我国鼓励仿制药品优先审评制度的现状及完善对策
- Author:
Xuli SUN
1
;
Shaoqing MA
1
Author Information
1. School of Humanities，Beijing University of Chinese Medicine，Beijing 102488，China
- Publication Type:Journal Article
- Keywords:
generic drugs;
encouraged generic drug catalogues;
priority review system;
improvement countermeasures
- From:
China Pharmacy
2023;34(2):129-132
- CountryChina
- Language:Chinese
-
Abstract:
OBJECTIVE To provide reference for better implementation of the priority review system for generic drugs of encouraged generic drug catalogues. METHODS Based on literature research， practical status of the priority review system for generic drugs in two batches of encouraged generic drug catalogues in China was analyzed， and the problems existing in the application of the system were compared to propose corresponding solutions. RESULTS & CONCLUSIONS China has issued two batches of encouraged generic drug catalogues， and there were 49 varieties of generic drugs included in the catalogues. In the implementation of the priority review system for generic drugs of encouraged generic drug catalogues， there were some problems in legislation， incentive system for the first generic drug， post-marketing re-evaluation system， and cross-departmental coordination and linkage mechanism. It is suggested to strengthen legislation， improve the “first generic market exclusivity period” system， perfect the post-marketing re-evaluation system and form a normalized cross-departmental coordination mechanism so as to ensure the safety， effectiveness and accessibility of generic drugs in China.
