Department of Orthopaedics, Osaka University Graduate School of Medicine, Osaka, Japan; Department of Medical Innovation, Osaka University Hospital, Osaka, Japan.
Division of Cell-Based Therapeutic Products, National Institute of Health Sciences, Kanagawa, Japan.
Clin Ther. 2018 Jul;40(7):1076-1083. doi: 10.1016/j.clinthera.2018.05.008. Epub 2018 Jun 27.
With its aim to regain the function of organs that are damaged by illness or injury, regenerative medicine has become the global focus of research. To accelerate the development and establishment of sufficient safety measures in regenerative medicine in Japan, the Pharmaceuticals and Medical Devices Act and the Act on Safety of Regenerative Medicine were enacted in 2014. Advancements in regenerative medicine are anticipated to draw attention toward the development of a system that consolidates and uses valuable data from studies performed from premarketing to postmarketing stages. Data gathered from premarketing to postmarketing stages of clinical research would promote new development avenues that would lead to the establishment of appropriate evaluation methods for new regenerative medical products by data validation. Against this background, the Japanese Society for Regenerative Medicine has been working to establish a national consortium for promoting regenerative medicine and constructing a large-scale clinical data registry, called the National Regenerative Medicine Database. This article aims to introduce the current framework of regenerative medicine in Japan, with a particular focus on the activity for establishment of a national consortium for regenerative medicine and the National Regenerative Medicine Database.
再生医学旨在恢复因疾病或损伤而受损的器官的功能，已成为全球研究的焦点。为了加速日本再生医学的发展和建立充分的安全措施，《药品和医疗器械法》和《再生医学安全法》于 2014 年颁布。预计再生医学的进步将引起人们对开发一种系统的关注，该系统将整合和利用从上市前到上市后阶段研究中获得的有价值数据。从临床研究的上市前到上市后阶段收集的数据将通过数据验证为新的再生医学产品的建立适当的评估方法提供新的发展途径。在此背景下，日本再生医学学会一直在努力建立一个促进再生医学的国家联盟，并构建一个大型的临床数据注册中心，称为国家再生医学数据库。本文旨在介绍日本再生医学的当前框架，特别关注再生医学国家联盟的建立活动和国家再生医学数据库。
