Current status of research on and approval of anti-epileptic drugs for children at home and abroad and its enlightenment for China
10.11665/j.issn.1000-5048.2024121603
- VernacularTitle:国内外儿童抗癫痫药研发上市现状研究及对我国的启示
- Author:
Jingfeng LIU
1
;
Yingyi XIAO
;
Xinyu LI
;
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 期刊文章
- Keywords:
pediatric drugs;
epilepsy;
research and development;
marketing approval;
incentive policies
- From:
Journal of China Pharmaceutical University
2025;56(5):661-666
- CountryChina
- Language:Chinese
-
Abstract:
To provide auxiliary decision-making support to improve incentive policies for pediatric drug development and approval, we systematically review the current status of research on and approval of anti-epileptic drugs (AEDs) for children at home and abroad, and comprehensively analyze the existing barriers in China’s pediatric AED development and market approval process. Findings reveal that China lags behind some countries and regions included in this comparative study (United State of America, European Union, Japan and Australia, etc.) in terms of research and development (R&D) capability and progress in pediatric AEDs, with significant disparity in the diversity of approved drugs, formulations, and dosage forms. It is recommended that China enhance its policy support for R&D, optimize the drug evaluation and approval system, strengthen the management of drug allocation and utilization, promote rational drug use, reinforce post-marketing incentive policies and help foster a more favorable policy environment for the development and approval of pediatric medications.
