Page 129 - 《中国药科大学学报》2025年第5期
P. 129
学报
Journal of China Pharmaceutical University 2025, 56(5): 661 − 666 661
·专 论·
国内外儿童抗癫痫药研发上市现状研究及对我国的启示
刘敬峰，肖英屹，李新宇，颜建周 *
（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）
摘 要 为完善我国儿童用药研发上市激励政策提供辅助决策依据，通过梳理国内外儿童抗癫痫药的研发上市现状，对比分
析我国在儿童抗癫痫药研发上市中存在的问题。研究发现我国儿童抗癫痫药在研发水平、研发进程上与纳入对比研究的国
家和地区（美国、欧盟、日本、澳大利亚，等）相比存在一定差距，在上市品种、剂型、规格的丰富程度上存在较大差距。建议
从完善研发环节支持政策、健全药品审评审批制度、加强药品配备使用管理、促进合理用药和强化上市后激励政策等方面发
力，持续优化儿童用药研发上市政策环境。
关键词 儿童用药；癫痫；研发；上市；激励政策
中图分类号 R971+.6；R956 文献标志码 A 文章编号 1000−5048(2025)05−0661−06
doi：10.11665/j.issn.1000−5048.2024121603
引用本文 刘敬峰，肖英屹，李新宇，等. 国内外儿童抗癫痫药研发上市现状研究及对我国的启示 [J]. 中国药科大学学报，2025，56（5）：
661 − 666.
Cite this article as: LIU Jingfeng, XIAO Yingyi, LI Xinyu, et al. Current status of research on and approval of anti-epileptic drugs for children
at home and abroad and its enlightenment for China[J]. J China Pharm Univ, 2025, 56(5): 661 − 666.
Current status of research on and approval of anti-epileptic drugs for children
at home and abroad and its enlightenment for China
LIU Jingfeng, XIAO Yingyi, LI Xinyu, YAN Jianzhou *
Research Center of National Drug Policy & Ecosystem, China Pharmaceutical University, Nanjing 211198, China
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.
Key words pediatric drugs; epilepsy; research and development; marketing approval; incentive policies
This study was supported by the National Natural Science Foundation of China (No.7227041015) and the Humanities and Social
Science Program of Ministry of Education (22YJAZH126)
儿童用药是儿童健康领域的关注重点。目前， 我国已进入“十四五”规划新发展阶段，社会对儿童
收稿日期 2024-12-16 * 通信作者 Tel：13852297503 E-mail：cpuqqyan@163.com
基金项目 国家自然科学基金项目（No.7227041015）；教育部人文社会科学研究规划基金项目（22YJAZH126）
