Okada Kiyoshi, Miyata Toshio, Sawa Yoshiki
Department of Orthopaedics, Osaka University Graduate School of Medicine, 2-2 Yamadaoka, Suita, Osaka, Japan.
Department of Medical Innovation, Osaka University Hospital, 2-15 Yamadaoka, Suita, Osaka, Japan.
Regen Med. 2017 Mar;12(2):179-186. doi: 10.2217/rme-2016-0124. Epub 2017 Feb 16.
In Japan, the Act on the Safety of Regenerative Medicine and the Pharmaceuticals, Medical Devices and Other Therapeutic Products Act were enacted in November 2014, creating a new framework for clinical research and products related to regenerative medicine. Together with these regulatory frameworks, new insurance procedures were created for handling regenerative medicine in Japan. For developing regenerative medicine in Japan, understanding medical insurance greatly influences funding and venture success, particularly in the stages between clinical research and market launch. The study aimed to identify the issues and examples surrounding Japan's present medical insurance system, especially for regenerative medicine. We believe that building stronger insurance systems for regenerative medicine is essential for internationally aligning and harmonizing the progress of regenerative medicine.
在日本,《再生医学安全法》以及《药品、医疗器械及其他治疗产品法》于2014年11月颁布,为再生医学相关的临床研究和产品创建了一个新框架。连同这些监管框架,日本还创建了用于处理再生医学的新保险程序。对于在日本开发再生医学而言,了解医疗保险对资金筹集和创业成功有很大影响,尤其是在临床研究和市场推出之间的阶段。该研究旨在确定围绕日本现行医疗保险制度的问题和实例,特别是针对再生医学的。我们认为,建立更强大的再生医学保险制度对于在国际上协调和统一再生医学的发展进程至关重要。