Foreign generic drug substitution policies for narrow therapeutic index drugs and their implications for China
10.11665/j.issn.1000-5048.2023092301
- VernacularTitle:域外国家窄治疗指数药品的仿制药替代政策及其对我国的启示
- Author:
Jingfeng LIU
1
;
Chenwei ZUO
;
Yangfan SHI
;
Jianzhou YAN
Author Information
1. 中国药科大学国家药物政策与医药产业经济研究中心, 南京211198
- Publication Type:Journal Article
- Keywords:
narrow therapeutic index drugs / generic drug substitution / safety and efficacy / typical measures
- From:
Journal of China Pharmaceutical University
2024;55(4):565-572
- CountryChina
- Language:Chinese
-
Abstract:
Abstract: In order to ensure the safety and efficacy of generic drugs for the substitution of narrow therapeutic index (NTI) drugs, and to improve and optimize China's generic drug substitution policy, we searched foreign literature databases and government websites to collect and sort out the typical measures taken by some foreign countries to ensure the safety and efficacy of generic drugs for the substitution of NTI drugs, including R&D registration, generic drug substitution and post-market surveillance. On the basis of comparative analysis, this paper summarizes the practices China can learn from. It can be seen that there are problems and challenges in China's generic drug substitution for NTI drugs, such as unclear targets for bioequivalence studies of NTI drugs, insufficient rational decision-making basis for generic substitution of NTI drugs, and imperfect post-market surveillance system, etc. It is recommended that we should formulate a list of NTI drugs, play the roles of physicians and pharmacists in generic drug substitution, adjust the generic drug substitution for NTI drugs according to the level of risk of drug use, and improve the reporting system for adverse reactions due to generic drug substitution.
