Research on the history and effect of incentive policy for pediatric drug development in China
HUANG Jian
YANG Yong
LU Xin
XIAN Xue-guo
YAO Zheng-rong
Abstract：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.
Keywords：childpediatric drugdrug discoveryincentive policies for pediatric drug developmentpolicy making
Publication Date：2025-04-30
Online Publishing Date：2026-08-14(First online date of this platform, not the publication date of the document)
Pages：7( 797-803 )