中国的儿科药物开发:中国儿科药物开发:现状与前景

IF 3.4 3区 医学 Q1 PEDIATRICS
Pediatric Drugs Pub Date : 2024-09-01 Epub Date: 2024-06-05 DOI:10.1007/s40272-024-00636-8
Lin Song, Ni Zhang, Ting-Ting Jiang, Yuntao Jia, Yao Liu
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引用次数: 0

摘要

二十多年来,世界各国的监管机构都发布了相关指南、规则和法律,以激励和帮助儿科药物开发。2014 年,国家卫生和计划生育委员会(现称国家卫生健康委员会)等五部门联合发布了《关于保障儿童用药的若干意见》,之后又出台了多项政策法规,落实儿童用药优先审评审批,支持儿童用药新剂型、新强度等新药研发。2018年至2022年共批准儿童特殊药品172个。2016年以来,国家卫生健康委会同有关行政部门制定发布了4个儿科药品目录,共129个药品,鼓励研发。目前,其中约25种药品(剂型和强度与目录完全一致)已获准上市,包括抗肿瘤药物和免疫调节剂、神经系统药物、精神障碍药物和罕见病药物。在本综述中,我们分析了中国为促进儿科药物开发而颁布的法规,包括优先审评审批制度、技术指导原则、数据保护和财政支持政策,以及儿科药物审批、临床试验和在上市药品标签中增加儿童用药信息的概况。最后,我们讨论了中国儿科药物研发面临的挑战和可能采取的策略。
本文章由计算机程序翻译,如有差异,请以英文原文为准。

Paediatric Drug Development in China: Current Status and Future Prospects.

Paediatric Drug Development in China: Current Status and Future Prospects.

For more than two decades, regulatory agencies throughout the world released guidelines, rules and laws to stimulate and assist in paediatric drug development. In 2014, the National Health and Family Planning Commission (now known as the National Health Commission, NHC) and five other departments in China jointly issued 'Several Opinions on Safeguarding Medication for Children', after which several policies and regulations were issued to implement the priority review and approval of paediatric medicinal products and support the development of new drugs, including new dosage forms and strengths, for children. A total of 172 special medicinal products for children were approved from 2018 to 2022. Since 2016, the NHC, together with relevant administrative departments, has formulated and issued four paediatric drug lists containing 129 medicinal products to encourage research and development. At present, approximately 25 of these drugs (at exactly the same dosage forms and strengths as on the lists) have been approved for marketing, including antitumour drugs and immunomodulators, nervous system drugs, drugs for mental disorders and drugs for rare diseases. In this review, we analysed the regulations issued for promoting paediatric drug development in China, including the priority review and approval system, technical guidelines, data protection and financial support policies and general profiles of paediatric drug approval, clinical trials and the addition of information for children in the labels of marketed medicinal products. Finally, we discussed the challenges and possible strategies in the research and development of paediatric drugs in China.

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来源期刊
Pediatric Drugs
Pediatric Drugs PEDIATRICS-PHARMACOLOGY & PHARMACY
CiteScore
7.20
自引率
0.00%
发文量
54
审稿时长
>12 weeks
期刊介绍: Pediatric Drugs promotes the optimization and advancement of all aspects of pharmacotherapy for healthcare professionals interested in pediatric drug therapy (including vaccines). The program of review and original research articles provides healthcare decision makers with clinically applicable knowledge on issues relevant to drug therapy in all areas of neonatology and the care of children and adolescents. The Journal includes: -overviews of contentious or emerging issues. -comprehensive narrative reviews of topics relating to the effective and safe management of drug therapy through all stages of pediatric development. -practical reviews covering optimum drug management of specific clinical situations. -systematic reviews that collate empirical evidence to answer a specific research question, using explicit, systematic methods as outlined by the PRISMA statement. -Adis Drug Reviews of the properties and place in therapy of both newer and established drugs in the pediatric population. -original research articles reporting the results of well-designed studies with a strong link to clinical practice, such as clinical pharmacodynamic and pharmacokinetic studies, clinical trials, meta-analyses, outcomes research, and pharmacoeconomic and pharmacoepidemiological studies. Additional digital features (including animated abstracts, video abstracts, slide decks, audio slides, instructional videos, infographics, podcasts and animations) can be published with articles; these are designed to increase the visibility, readership and educational value of the journal’s content. In addition, articles published in Pediatric Drugs may be accompanied by plain language summaries to assist readers who have some knowledge of, but not in-depth expertise in, the area to understand important medical advances.
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