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首页> 外文期刊>臨床評価: Clinical evaluation >Nonclinical data required for clinical application of induced pluripotent stem cells (iPSCs)-based products Critique of Japanese Notifications compared with the policies of FDA and EMA
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Nonclinical data required for clinical application of induced pluripotent stem cells (iPSCs)-based products Critique of Japanese Notifications compared with the policies of FDA and EMA

机译：与FDA和EMA的政策相比，诱导多能干细胞（IPSCS）的临床应用所需的非临床资料所需的诱导多能干细胞（IPSC）的产品批判

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Clinical development of regenerative medicine using somatic stem cells is making steady progress toward practical application all over the world. Needless to say, clinical trials of cellular-based products are regarded as being in the experimental stage in the world and mostly have been conducted under the Pharmaceutical Affairs Law (PAL). Therefore, their efficacy and safety are rigorously evaluated by regulatory authorities based on quality-assured preclinical and clinical data, aiming at the goal of marketing authorization.Currently in Japan, several investigator-initiated regenerative medicine clinical trials under the PAL have steadily achieved planned progress. On the other hand, "clinical research of iPSCs (induced pluripotent stem cells)" outside the control of PAL has been rapidly accelerated toward clinical application.Considering this situation, we reviewed Japanese regulations related to preclinical assessment of cellular-based products, comparing with the regulatory policies of the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA). We found that Japanese regulations of regenerative medicine using cellular-based products mainly focus on quality control and manufacturing of cell preparations, while both the FDA and EMA intensively discuss about preclinical studies of cell preparations and risk factor examination, apart from the issue of manufacturing.We conclude that in Japan all the clinical trials of cellular-based products should be conducted under the control of PAL and that regulatory science concerning preclinical and clinical assessment of such products should be discussed in greater depth based on the examination of FDA/EMA policies.
机译：使用体细胞干细胞进行再生药的临床开发是对世界各地的实际应用的稳步发展。不用说，基于细胞的产品的临床试验被认为是在世界的实验阶段，并且主要是在制药法（PAL）下进行的。因此，他们的疗效和安全性通过基于质量保证的临床前和临床资料，旨在营销授权的目标严格评估。在日本，他在PAL下的一些调查员启动的再生医学临床试验稳步实现了计划进展。另一方面，“PAL控制范围”的“IPSC（诱导多能干细胞）的临床研究已经迅速加速了临床应用。考虑了这种情况，我们审查了与细胞基产品的临床前评估相关的日本法规，比较美国食品和药物管理局（FDA）和欧洲药物局（EMA）的监管政策。我们发现，使用基于细胞的产品的日本再生药物法规主要关注细胞制剂的质量控制和制造，而FDA和EMA则对细胞制剂的临床前研究和风险因素考试的临床前研究，除了制造问题。我们得出结论，在日本，在PAL的控制下，应在PAL的控制下进行细胞基产品的所有临床试验，并且应根据对FDA / EMA政策的审查更深入地讨论关于这种产品的临床前和临床评估的监管科学。

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