Tobita Morikuni, Konomi Kenji, Torashima Yasuhiro, Kimura Kenichi, Taoka Masaomi, Kaminota Masahiro
Office for Promotion of Regenerative Medicine, Research and Development Division, Health Policy Bureau, Ministry of Health, Labour and Welfare, The Government of Japan, Japan.
Office of Cellular and Tissue-based Products, Pharmaceuticals and Medical Devices Agency, Japan.
Regen Ther. 2016 May 31;4:78-81. doi: 10.1016/j.reth.2016.04.001. eCollection 2016 Jun.
The first issue of published 20 years ago featured an article that reported Japan's critical situation regarding clinical trials, calling for major reform. Twenty years later, Japan has enacted three laws to promote the use of regenerative medicine as a national policy. The first law to be enacted was the Regenerative Medicine Promotion Act, which represents the country's determination to work toward the promotion of regenerative medicine. Subsequently, the Pharmaceuticals, Medical Devices, and Other Therapeutic Products Act (PMD Act) and the Act on the Safety of Regenerative Medicine (RM Act) came into effect. The PMD Act created a new category for regenerative medicine products, and established the process for obtaining approval for cell therapy and other regenerative therapies through the implementation of clinical trials. The RM Act specified the regulations that doctors, review committees, and cell culture/processing facilities must adhere to when providing regenerative medicine in medical care, not only in clinical research but also in private practice. Previously, researchers in regenerative medicine only had a set of guidelines to follow for conducting clinical research. Now, with the enactment of the RM Act, all areas for improvement that had been enumerated 20 years ago-such as the lack of appropriate review committees and governmental control-have been addressed by law, creating a system that gives the highest priority to patient safety. In this paper, we present the particularly noteworthy points of the RM Act, along with the actual current conditions of regenerative medicine in Japanese medical care.
20年前出版的第一期杂志上有一篇文章报道了日本临床试验的严峻形势，呼吁进行重大改革。20年后，日本颁布了三项法律，将促进再生医学的应用作为国家政策。第一部颁布的法律是《再生医学促进法》，这表明了该国致力于促进再生医学发展的决心。随后，《药品、医疗器械及其他治疗产品法》（PMD法）和《再生医学安全法》（RM法）生效。PMD法为再生医学产品设立了一个新类别，并确立了通过开展临床试验获得细胞治疗及其他再生疗法批准的程序。RM法规定了医生、审查委员会以及细胞培养/加工设施在医疗护理中提供再生医学时（不仅是在临床研究中，也包括在私人执业中）必须遵守的规定。以前，再生医学研究人员在进行临床研究时只有一套指导方针可循。现在，随着RM法的颁布，20年前列举的所有需要改进的方面——比如缺乏适当的审查委员会和政府监管——都已通过法律得到解决，创建了一个将患者安全置于最高优先地位的体系。在本文中，我们介绍了RM法特别值得注意的要点，以及日本医疗护理中再生医学的实际现状。
