Analyzing the Impact of Japan’s Regenerative Medicine Regulatory Reforms
February 2, 2018 Keio University
In 2014, the Japanese government introduced a number of regulatory reforms intended to accelerate the development of regenerative medicine. These included a new legislation, namely the Act on Safety of Regenerative Medicine (ASRM), which created a risk-based approach for the review and oversight of cell-based therapies at private clinics. In an article in Cell Stem Cell, researchers at the Keio University Global Research Institute (KGRI), Project Professor Douglas Sipp and Professor Hideyuki Okano, examine the impact that this law has had on the domestic regenerative medicine industry in Japan. They report the great majority (~97%) of “regenerative medicine” procedures registered under ASRM fall under the most lightly regulated category. This number includes many cell-based interventions, such as immunotherapies for the treatment of cancer that are not primarily regenerative in nature. Sipp and Okano also outline a number of measures that are being introduced by the Ministry of Health, Labour and Welfare in an effort to increase transparency and accountability in this sector.