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Enabling Development of Paediatric Medicines in Europe: 10 Years of the EU Paediatric Regulation

机译：在欧洲的开发促进儿科药物：10年的欧盟儿科规例

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Abstract The year 2017 marks the tenth anniversary of entry into force of the Paediatric Regulation in the European Union (EU). This law aimed to stimulate the development of paediatric medicines and provide more information on their use, as a response to the lack of evidence and approval of medicines for children. The European Medicines Agency (EMA) has had a central role in the implementation of the Regulation. Pharmaceutical companies need to submit a paediatric investigation plan (PIP) to the EMA’s Paediatric Committee (PDCO) for every new medicine, unless an exemption (waiver) is granted. The plans, which describe the development of drugs for children, must be agreed well in advance of the request for marketing authorization of the medicine. Deferrals of studies can be granted to allow approval in adults before the completion of paediatric studies. Between January 2007 and December 2016, a total of 273 new medicines and 43 additional pharmaceutical forms appropriate for use in children were authorized in the EU, and 950 PIPs were agreed by the EMA. In addition, 486 waivers of the development of a medicine in one or more medical conditions were agreed. The Paediatric Regulation has had a very positive impact on paediatric drug development, as exemplified by a comparison of two periods of 3?years before and after entry into force of the Regulation. We conclude that the Regulation has resulted in more medicines for children and more information on the pediatric use of medicines in the EU being available to clinicians.
机译：摘要2017年，标志着欧洲联盟（欧盟）的儿科规定生效第十周年。这项法律旨在刺激儿科药物的发展，并提供更多关于其使用的信息，作为对缺乏儿童药物的证据和批准的回应。欧洲药物局（EMA）在执行监管方面具有核心作用。除非授予豁免（豁免），否则制药公司需要向EMA的小儿科委员会（PDCO）提交给EMA的儿科委员会（PDCO）。描述儿童毒品发展的计划，必须在营销销售授权的药物的提前达成一致。可以在进行儿科研究之前允许允许在成人批准后进行研究。 2016年1月至2016年1月至12月，欧盟授权共有273家新药和43名适合用于儿童的药物形式，并通过EMA达成950个点。此外，达成了486名豁免一个或多个医疗病症的药物的发展。儿科调节对儿科药物发展产生了非常积极的影响，如下所示的三个月和经调节效力前后的3年的比较。我们得出结论，该监管导致了更多的儿童药物以及更多关于临床医生可用的欧盟药物儿科使用的信息。

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