我国儿科药物研发激励政策发展历程及成效分析  

Research on the history and effect of incentive policy forpediatric drug development in China

作　　者：黄坚 杨勇 陆信 冼学国 姚峥嵘 HUANG Jian;YANG Yong;LU Xin;XIAN Xue-guo;YAO Zheng-rong(School of Health Economics and Management,Nanjing University of Chinese Medicine,Nanjing 210023,China;School of Pharmaceutical Sciences,Nanjing University of Chinese Medicine,Nanjing 210023,China;School of Nursing,Nanjing University of Chinese Medicine,Nanjing 210023,China)

机构地区：[1]南京中医药大学卫生经济管理学院,南京210023 [2]南京中医药大学药学院,南京210023 [3]南京中医药大学护理学院,南京210023

出　　处：《中国新药杂志》2025年第8期797-803,共7页Chinese Journal of New Drugs

基　　金：2024年江苏省研究生科研与实践创新计划资助项目(SJCX24_0837);江苏中医药传承创新发展研究基地2024年度开放课题(JSZYYJD2024A03);江苏省社会科学基金项目:长三角一体化下联动构建儿童药全链条政策组合路径研究(24GLD003)。

摘　　要：本文通过梳理我国儿科药物研发激励政策的发展历程,探索我国儿科药物研发激励政策实施成效,并与欧盟和美国相关政策及成效进行比较,旨在为我国儿科药物的进一步发展提供建议。采用文献研究法对我国儿科药物研发激励政策及相关指导文件进行分析,收集国家药品监督管理局药品审评中心官网的数据资料,对我国2019—2023年儿科药物批准上市和临床试验数据进行统计分析。2014—2023年,我国共发布保障儿童用药相关政策88个,发布儿童药物研发相关技术指导17个。2019—2023年儿童人群药物临床试验受理数量和药物批准上市数量逐年递增,其中2023年仅在儿童人群中开展的临床试验有104项,与2022年相比增加了62.5%;2023年批准上市儿童药品92个,有26个儿童药品通过“优先审评审批”程序获批上市,均创历史新高。我国儿科药物研发激励政策取得良好成效,国家应进一步加大儿童药物研发经济投入和政策支持,激励儿童专用药品研发。This article reviews the development history of China's pediatric drug research and development incentive policy,explores its implementation effect,and compares it with the relevant policies and results in Europe and the United States,aiming to provide suggestions for the further development of pediatric drugs in China.Literature research method was used to analyze the incentive policies and related guidance documents for pediatric drug research and development in China,data were collected from the official websites of NMPA and CDE,and the data of pediatric drug approval and clinical trials in China from 2019 to 2023 were statistically analyzed.From 2014 to 2023,the state issued a total of 88 policies to guarantee pediatric drugs and 17 technical guidance related to pediatric drug research and development.From 2019 to 2023,the number of drug clinical trials accepted in children and the number of drug marketing approvals increased year by year,among which 104 clinical trials were carried out only in children in 2023,with an increase of 62.5%compared with 2022.In 2023,92 pediatric drugs were approved for listing,and 26 pediatric drugs were approved for listing through the“priority review and approval”process,all reaching a record high.China's pediatric drug research and development incentive policy has achieved good results.The state should further increase the economic investment and policy support of pediatric drug research and development and encourage the research and development of child specific drugs.

关 键 词：儿童 儿童用药 药物研发 研发激励政策 政策制定 

分 类 号：R95[医药卫生—药学]