Review of the competitive generic drug incentive system in the United States and its enlightenment to China
- VernacularTitle:美国竞争性仿制药激励制度述评及对我国的启示
- Author:
Silun GUO
1
;
Shaoqing MA
1
Author Information
1. School of Humanities，Beijing University of Chinese Medicine，Beijing 102488，China
- Publication Type:Journal Article
- Keywords:
competitive generic drug incentive system;
the United States;
implementation effect;
system reference
- From:
China Pharmacy
2023;34(13):1562-1566
- CountryChina
- Language:Chinese
-
Abstract:
OBJECTIVE To provide ideas and inspiration for promoting the development of the generic drug industry and legal system of China. METHODS With text analysis， empirical research and other methods， the competitive generic drug incentive system in the United States was combed， its implementation effect and successful experience were analyzed， and the reference was provided for the implementation of relevant systems in China. RESULTS The competitive generic drug incentive system in the United States had achieved a satisfactory effect in three aspects： encouraging generic drug applications， accelerating the listing of generic drugs， and promoting drug price reduction， which was ultimately conducive to improving drug accessibility by publishing List of Off-Patent，Off-Exclusivity Drugs without an Approved Generic， while accelerating the development and review of generic drugs with insufficient competition and giving market exclusivity periods. CONCLUSIONS China’s reference to the competitive generic drug incentive system in the United States meets the needs of the current situation of domestic drug supply and also has the basis for industry practice. Therefore， we can refer to it， improve the system of releasing the catalog of encouraged generic drugs to be imitated， optimize the approval process for them， and authorize the exclusive period incentive to them.
