摘要
目的 为更新完善我国现行基本药物目录体系,制定儿童专属基本药物目录,鼓励儿童用药研发生产,提高儿童用药可及性、安全性提供参考依据及实施路径。方法 采用对比分析与描述性分析方法 ,对第9版《WHO儿童基本药物目录》(WHOEMLc)的药物分类、剂型规格、疾病谱覆盖及特殊标识等进行统计分析,并与2018年版《国家基本药物目录》(NEML)以及2016-2024年国家卫生健康委员会发布的5批《鼓励研发申报儿童药品清单》进行比较,综合评估第9版WHOEMLc药物在我国的可获得性。结果 与结论 两类目录差异较为明显,总体重合药物有101种,占第9版WHOEMLc药物总量的27.98%。第9版WHOEMLc相较于2018年版NEML,在儿童适宜药物种类多样性、剂型适配性及规格精准性等方面优势显著;《鼓励研发申报儿童药品清单》一定程度上填补了我国儿童用药的空缺,丰富了儿童用药品种和剂型选择,但其中未上市的药物占近80%,仍存在研发转化率偏低、政策激励效果不足等问题。建议结合我国国情,借鉴WHO和发达国家、地区儿童药物遴选经验,建立分级分类的儿童专属基本药物目录,加大对儿童适宜药物剂型、规格研发的支持力度,强化申报、审评、采购等全周期政策倾斜,鼓励开展儿童用药循证医学实践,加快儿童基本药物研发、上市及遴选进程,保障儿童用药可获得性。
OBJECTIVE To offer references and implementation paths for updating and enhancing the China’s current essential medicines list system,formulating a specific list of essential medicines for children in China,promoting the research and development of pediatric medications,and improving the accessibility and safety of pediatric medications for children.METHODS Comparative and descriptive analysis was utilized to statistically analyze the classification,dosage forms,specifications,disease spectrum,and symbolic annotations of the 9th edition of the WHO Model List of Essential Medicines for Children(WHO EMLc).Differences were compared among WHO EMLc,the 2018 National Essential Medicines List(NEML),and five batches of the List of Encouraged R&D and Declaration of Pediatric Drugs issued by the National Health Commission from 2016 to 2024.The availability of drugs in the 9th edition of WHO EMLc in China was discussed.RESULTS&CONCLUSIONS The differences between the two lists were relatively substantial.A total of 101 drugs overlapped,accounting for 27.98%of the total number of drugs in the 9th edition of the WHO EMLc.Compared with the 2018 NEML,the 9th edition of the WHO EMLc showed notable advantages in the diversity of pediatric-appropriate drug types,dosage form adaptability,and specification precision.The List of Encouraged R&D and Declaration of Pediatric Drugs,to some extent,had filled the gap in China’s pediatric medications,enriching the variety of drug types and dosage forms for children.However,nearly 80%of the drugs on the list were not yet marketed,still facing problems such as a low R&D conversion rate and insufficient policy incentive effects.It is recommended to establish a tiered and classified pediatric essential medicines list based on China’s national conditions,drawing on the selection experience of the WHO and developed countries/regions;strengthen support for the R&D of appropriate pediatric dosage forms and specifications;implement policy preferences throughout the entire cycle of application,review and procurement;encourage evidence-based pediatric practices,accelerate the R&D,market launch,and selection processes of pediatric essential medicines,and ensure the accessibility of pediatric medicines.
作者
孙云龙
赖欣
田磊
SUN Yunlong;LAI Xin;TIAN Lei(School of International Pharmaceutical Business,China Pharmaceutical University,Nanjing 211198,China)
出处
《中国药房》
北大核心
2025年第21期2621-2626,共6页
China Pharmacy
基金
国家自然科学基金项目(No.72274217)。
关键词
WHO儿童基本药物目录
国家基本药物目录
儿童用药
药物遴选
WHO Model List of Essential Medicines for Children
National Essential Medicines List
pediatric medication
drug selection
