Regulatory perspectives of Japan

Abstract

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.

Keywords: Act on Pharmaceuticals and Medical Devices; Act on the Safety of Regenerative Medicines; Cell and gene therapy; Expedited approval system; Regenerative Medicine Promotion Law; Regenerative medicine.