Kusakabe Tetsuya
Ministry of Health, Labour and Welfare, 1-2-2 Kasumigaseki, Chiyoda-ku, Tokyo 100-8916, Japan.
Biologicals. 2015 Sep;43(5):422-4. doi: 10.1016/j.biologicals.2015.05.003. Epub 2015 May 29.
In this article, the 2013 regenerative medicine laws and regulations in Japan are addressed. The Regenerative Medicine Promotion Law was promulgated in May 2013 to promote comprehensive measures from research and development to practical use of regenerative medicines. In line with this purpose, two acts have been passed by the National Diet in November 2013. One is the Act on the Safety of Regenerative Medicine, which classifies regenerative medicines based on risk. Additionally this Act stipulates the procedures for offering regenerative medicines, the measures for appropriate provision of the regenerative medicines, and authorization to manufacture designated cellular therapeutic products for therapeutic use. The other is the Act on Pharmaceuticals and Medical Devices, previously named the Pharmaceutical Affairs Act, which establishes regulations tailored to the characteristics of regenerative medicinal products, including an expedited approval system.
本文探讨了2013年日本的再生医学法律法规。《再生医学促进法》于2013年5月颁布，以推动从再生医学研发到实际应用的综合措施。出于这一目的，国会于2013年11月通过了两项法案。一项是《再生医学安全法》，该法根据风险对再生医学进行分类。此外，该法规定了提供再生医学的程序、适当提供再生医学的措施以及制造指定用于治疗的细胞治疗产品的授权。另一项是《药品和医疗器械法》，其前身为《药事法》，该法制定了针对再生医药产品特点的法规，包括快速审批制度。
