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Pediatric Medicine Development: An Overview and Comparison of Regulatory Processes in the European Union and United States

机译：儿科医学发展：欧盟和美国监管程序的概述和比较

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摘要

Pediatric legislation in the US and the EU is driving pediatric product development on an international scale. To facilitate harmonization and global development of pediatric medicines, it is important to understand the legislative requirements that must be met along with incentives that exist in the US and the EU to include pediatric patients in therapeutic clinical trials. Although there are many similarities, differences exist. This review is an effort to enhance understanding of the pediatric legislation in both regions. It is intended as an overview to supplement the region-specific legislation and guidance documents that are available on the websites of the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA). Despite differences, the goal of the legislation in both the EU and the US is to incentivize and require timely, ethical, and sound scientific development of pharmaceutical products for the pediatric population and to provide information for their safe and effective use.

机译：美国和欧盟的儿科立法正在推动国际范围内的儿科产品开发。为了促进儿科药物的协调和全球发展，重要的是要了解必须满足的立法要求以及美国和欧盟存在的将儿科患者纳入治疗性临床试验的激励措施。尽管有很多相似之处，但存在差异。这项审查旨在加深对这两个地区的儿科法规的了解。它旨在作为补充，以补充在美国食品和药物管理局（FDA）和欧洲药品管理局（EMA）网站上提供的针对特定地区的法律和指导文件。尽管存在分歧，但欧盟和美国的立法目标都是激励和要求针对儿科人群的药品的及时，合乎道德和健全的科学发展，并提供有关其安全有效使用的信息。

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期刊名称 other
作者
Dobromir Penkov; Paolo Tomasi; Irmgard Eichler; Dianne Murphy; Lynne P. Yao; Jean Temeck;
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作者单位

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年(卷),期 -1(51),3
年度 -1
页码 360–371
总页数 21
原文格式 PDF
正文语种
中图分类
关键词
EU Paediatric Regulation Paediatric Committee Best Pharmaceuticals for Children Act (BPCA) Pediatric Research Equity Act (PREA) Pediatric Review Committee (PeRC);

机译：欧盟儿科法规;儿科委员会;儿童最佳药品法案（BPCA）;儿科研究公平法案（PREA）;儿科审查委员会（PeRC）;

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机译：P84？由美国（美国）食品和药物管理局（FDA）和欧盟（EU）欧洲药品管理局（EMA）触发的小儿肿瘤研究的目标是标签，而不是改善治疗。有些人通过暴露于不合标准的单一疗法而不是联合治疗而伤害年轻患者
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机译：在美国发展作为特殊专业的儿科急诊医学和倡导儿科医疗保健的非常概括的概述；向其他国家收费
7. P84 Pediatric oncology studies triggered by the united states (US) food and drug administration (FDA) and the european union (EU) european medicines agency (EMA) aim at labels, not at improved treatment. Some harm young patients by exposing them to substandard monotherapy instead of combination treatment [O] . K Rose 2019

机译：由美国（美国）食品和药物管理局（FDA）和欧洲联盟（欧盟）欧洲药物局（EMA）瞄准标签，而不是改善治疗的欧洲药物和药物肿瘤学研究。一些伤害年轻患者通过将它们暴露于不合标准的单疗法而不是组合治疗

Pediatric Medicine Development: An Overview and Comparison of Regulatory Processes in the European Union and United States

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