中国医院用药评价与分析2025，Vol.25Issue(5)：536-538,544,4.DOI:10.14009/j.issn.1672-2124.2025.05.005
《鼓励研发申报儿童药品清单》政策下的儿童用药现状分析
Analysis of Medication for Children Under the Policy of"List of Children's Drugs Encouraged for Research,Development and Declaration"
摘要
Abstract
OBJECTIVE:To analyze the current situation of children's medication under the policy of children's drugs encouraged for research,development and declaration in China,summarize the clinical and research and development factors that restrict children's medication,and provide references for the research and development of children's drugs in China.METHODS:Through public databases such as the official websites of the National Medical Products Administration,the Center for Drug Evaluation,and the China Pediatric Drug Database,the marketing approval status,indications,priority review,policy characteristics and implementation status of the drugs on five batches of"List of Children's Drugs Encouraged for Research,Development and Declaration"issued by China were retrieved,analyzed and summarized.RESULTS:Of the 144 drugs listed in the five batches of"List of Children's Drugs Encouraged for Research,Development and Declaration",only 25 were domestically developed,and some were imported,yet there were no domestically developed drugs and dosage forms.In the priority review,the proportion of children's medication showed an upward trend year by year.Cancer,tumors and infections,epilepsy and convulsions were the key fields of research and development for children's medication in China.CONCLUSIONS:Currently,the number of new drugs in the field of research and development for children's medication is small,and the dosage form and specification are not perfect.It is recommended that manufacturing enterprises increase their research efforts under the encouragement of policies to meet the clinical medication needs of children in China.关键词
鼓励清单/儿童用药/政策/限制因素Key words
List of incentives/Medication for children/Policy/Limiting factors分类
药学引用本文复制引用
姜德芳,王广飞,朱琳,袁明清,李智平..《鼓励研发申报儿童药品清单》政策下的儿童用药现状分析[J].中国医院用药评价与分析,2025,25(5):536-538,544,4.基金项目
2022年东方英才计划领军项目(原上海领军人才)(No.EK00000861) （原上海领军人才）
上海市市级医院诊疗技术推广及优化管理项目(No.SHDC22024204) （No.SHDC22024204）
上海市医药卫生发展基金会项目(No.20221128) （No.20221128）
长三角儿童临时调配制剂中心管理体系及区域流通模式探讨(儿童健康与政策研究中心项目2023立项课题)(No.2023RCCHP02) （儿童健康与政策研究中心项目2023立项课题）
