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首页> 外文期刊>Journal of tissue engineering and regenerative medicine >Comparison of the new Japanese legislation for expedited approval of regenerative medicine products with the existing systems in the USA and European Union
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Comparison of the new Japanese legislation for expedited approval of regenerative medicine products with the existing systems in the USA and European Union

机译：新日本立法与美国和欧盟现有系统加快再生药品批准的新立法

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Legislation for expedited-approval pathways and programmes for drugs, biologics or medical devices has been enacted for rapid commercialization of innovative products in the United States of America (USA) and the European Union (EU). However, less innovative products are increasingly benefitting from these expedited-approval pathways, and obligations to collect and report post-marketing data on approved products are being bypassed frequently. The Japanese government recently enacted legislation for a new conditional and time-limited approval pathway dedicated to regenerative medicine products. The current study examines this new legislation and compares it with existing US and EU regulatory frameworks, with a particular focus on how it addresses the limitations of existing systems. Regulations, guidance documents and approval information were gathered from the websites of the respective authorities in the USA, the EU and Japan, and the systems were categorized through qualitative analysis. The pathways and programmes from each region were categorized into four groups, based on the requirement of pre- or post-marketing clinical data. Expedited-approval pathways in the USA and the EU provide similar qualification criteria, such as severity of target disease; however, such criteria are not specified for the new pathway in Japan. Only the Japanese pathway stipulates a time limitation on exceptional approval, requiring post-marketing study for conditional and time-limited products. Continuous improvement is necessary to solve previously addressed issues within the expedited-approval pathways and programmes and to ensure that innovative medical products are rigourously screened, but also readily available to patients in need. The time limitation of conditional approval could be a potential solution to some of these problems. Copyright (c) 2017 The Authors. Tissue Engineering Regenerative Medicine published by John Wiley & Sons, Ltd.
机译：为美利坚合众国（美国）和欧洲联盟（欧盟）的创新产品的快速商业化而颁布了加速批准途径和药物，生物学或医疗设备方案的立法。然而，较少的创新产品越来越受益于这些加速批准的途径，并且频繁地绕过了收集和报告批量产品售后数据的义务。日本政府最近颁布了致力于再生药品的新的条件和时间限制批准途径立法。目前的研究审查了这一新立法，并将其与现有的美国和欧盟监管框架进行了比较，特别关注如何解决现有系统的局限性。法规，指导文件和批准信息收集来自美国，欧盟和日本各自当局的网站，系统通过定性分析进行分类。根据预售或营销后临床数据的要求，每个地区的途径和节目分为四组。美国和欧盟的加速批准途径提供类似的资格标准，例如目标疾病的严重程度;但是，在日本的新途径上没有指定此类标准。只有日本途径缩短了卓越批准的时间限制，需要营销后的有条件和有时限制的产品。持续改进是必要的，以解决先前讨论的加速批准途径和方案中的问题，并确保创新的医疗产品严重筛查，也可以随时可用。条件批准的时间限制可能是对其中一些问题的潜在解决方案。版权所有（c）2017作者。 John Wiley＆Sons，Ltd.出版的组织工程再生医学

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