首页|从儿童基本药物上市情况浅析我国儿童用药开发需求与建议

从儿童基本药物上市情况浅析我国儿童用药开发需求与建议

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我国儿童用药需求量大,而由于儿童用药研发难度大、临床试验开展困难、研发成本高等原因,儿童用药短缺问题长期存在.本文基于世界卫生组织(WHO)发布的第8版儿童基本药物目录和国家药监局发布的鼓励研发申报儿童药品清单,对我国已上市的儿童用药进行整理统计,重点分析我国儿童专用药、成人与儿童共用药和经验性用药的短缺情况.根据儿科临床需求及目前上市情况,可重点关注:作用于呼吸道的吸入制剂开发;免疫调节剂和抗肿瘤药物、眼科或皮肤科用药的用法用量优化;罕见病用药、心血管疾病用药、内分泌疾病用药的新品种、新剂型开发.另外,促进境外药品在国内上市、口服液体制剂开发新剂型、成人用注射剂改小剂量、鼓励或保护政策制定等可有效加速解决儿童用药短缺问题.
Analysis of the Demand and Suggestions for Pediatric Medication Development in China Based on the Market Status of Essential Drugs for Children
China faces a significant demand for pediatric medications.However,the challenges of developing children's drugs-such as the difficulty of conducting clinical trials,high R&D costs,and technical complexities-have led to a long-standing shortage of children's drugs.This study analyzes the market availability of children's medicines in China based on the eighth edition of the World Health Organization's(WHO)Model List of Essential Medicines for Children and the list of pediatric drugs encouraged for development by the National Medical Products Administration(NMPA).The analysis focuses on shortages in pediatric-specific drugs,shared adult-pediatric medications,and empirically used drugs.Based on pediatric clinical needs and current market conditions,priority areas identified include:development of inhaled formulations for respiratory conditions,optimization of dosing for immunomodulators,anti-cancer drugs,ophthalmic and dermatological medications;and development of new products and formulations for rare disease,cardiovascular diseases,and endocrine disorders.Additionally,strategies such as expediting the introduction of foreign pediatric drugs into the domestic market,developing new oral liquid formulations,downsizing adult injectable doses for pediatric use,and establishing supportive policies could effectively mitigate pediatric drug shortages.

pediatric medicationmarket statusdrug shortagedrug developmentpediatric clinical needs

涂慧丹、郭春彦、游龙泰、姚尚辰、戚淑叶、宁保明

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中国食品药品检定研究院

首都医科大学附属北京儿童医院

儿童用药 上市情况 短缺情况 药品开发 儿科临床需求

2024

中国食品药品监管
中国医药报社

中国食品药品监管

影响因子:0.099
ISSN:1673-5390
年,卷(期):2024.(11)