中国药房2025，Vol.36Issue(5)：519-523,5.DOI:10.6039/j.issn.1001-0408.2025.05.02
我国优先审评审批上市儿童用药的特征分析
Characteristics analysis of pediatric medicines with priority review and approval for marketing in China
摘要
Abstract
OBJECTIVE To analyze the characteristics of pediatric medicines with priority review and approval for marketing in China,providing a reference for promoting enterprise R&D and production,as well as improving the supply guarantee mechanism for pediatric medicines.METHODS Based on publicly available data sources such as List of Approved Information for Pediatric Medications Subject to Priority Review and Approval,Pharnexcloud biomedical database,and National Medical Insurance Drug Directory,this study conducted a comprehensive analysis of the main characteristics of pediatric medicines with priority review and approval for marketing.RESULTS As of June 30,2024,a total of 68 pediatric medicines had been approved through the priority review and approval process,covering 12 therapeutic areas,with oral dosage forms accounting for 64.71％.The median time from application to inclusion in priority review was 35.50 days,with an average of 41.69 days.The median time from inclusion in priority review to market approval was 1.24 years,with an average of 1.42 years.This included 12 domestic new medicines,21 domestic generic medicines,35 imported medicines,as well as 29 pediatric-specific medicines and 21 orphan medicines.Additionally,31 of these medicines had been included in the medical insurance catalog,representing a proportion of 45.59％.CONCLUSIONS Currently,a trend of differentiated competition is emerging between domestic and imported pediatric medicines.The therapeutic areas for pediatric medicines are continuously expanding,and the dosage forms are becoming more tailored to children's needs.However,there are still issues such as slow progress in new medicine development,insufficient stability in the medicine review and approval process,and a need to increase the proportion of medicines included in medical insurance.关键词
优先审评审批/儿童用药/儿童专用药/罕见病用药Key words
priority review and approval/pediatric medicines/child-specific medicines/medicines for rare diseases分类
医药卫生引用本文复制引用
杨浩宇,田侃,游雪,淡宏伟,王乾,喻小勇..我国优先审评审批上市儿童用药的特征分析[J].中国药房,2025,36(5):519-523,5.基金项目
江苏省社会科学基金后期资助项目(No.20HQ019) （No.20HQ019）
江苏省研究生科研创新计划项目(No.KYCX24_2114) （No.KYCX24_2114）
南京中医药大学养老服务与管理学院(养老产业学院)专项研究立项项目(No.2024YLFWYGL002) （养老产业学院）
