政策驱动下中国儿童用药发展成效分析.pdfVIP

ChineseJournalofNewDrugs2025,34(13)

·新药述评与论坛·

政策驱动下中国儿童用药发展成效分析

梁宇光,丁倩,王谦,张萌,郭春彦,郭鹏*

（国家儿童医学中心/首都医科大学附属北京儿童医院临床研究中心，北京100045）

［摘要】儿童用药市场长期面临药品种类不足、剂型不适、研发投入低等困难，严重影响了儿童健康需

求的满足。近年来，我国政府出台了一系列政策，旨在提升儿童药品的研发效率、优化审评审批流程并提高

药品的市场可及性。本文基于政策背景和中国儿童药品市场现状，深入分析这些政策在推动临床试验开展、

促进审评审批和市场准入3个方面的具体作用，探讨其对儿童健康需求的满足和药品市场发展的综合影响。

【关键词］儿童用药；政策支持；临床试验；审评审批；药品可及性

[中图分类号］R95[文献标志码]A

Ananalysisofthedevelopmentachievementsinpediatric

drugsinChinadrivenbypolicy

LIANGYu-guang,DINGQian,WANGQian,ZHANGMeng,GUOChun-yan,GUOPeng

(ClinicalResearchCenter,NationalCenterforChildrensHealth/BeijingChildrensHospital,

CapitalMedicalUniversity,Beijing100045,China)

[Abstract]Thepediatricdrugmarkethaslongfacedchallengessuchasinsufficientdrugtypes,uncomfortable

dosageformsandlowresearchanddevelopmentinvestment,whichhaveseverelyhinderedthefulfillmentofchildrens

healthneeds.Inrecentyears,theChinesegovernmenthasissuedaseriesofpoliciesaimedatimprovingtheresearch

anddevelopmentefficiencyofpediatricdrugs,optimizingthereviewandapprovalprocesses,andimprovingthe

accessibilityofdrugsinthemarket.Basedonthepolicybackgroundandthecurrentsituationofthepediatricdrug

marketinChina,thispaperdeeplyanalyzesthespecificroleofthesepoliciesinpromotingthedevelopmentofclinical

trials,promotingreviewandapprovalandmarketaccess,anddiscussestheircomprehensiveimpactonthesatisfaction

ofchildrenshealthneedsandthedevelopmentofthedrugmarket.

[Keywords]pediatricmedication;policysupport;clinicaltrial;reviewandapproval;drugaccessibility

儿童用药市场的发展对于保障儿童健康、提升特征的特殊性，儿童用药存在研发成本高昂、成果转

社会整体