2014 Volume 4 Issue 3 Pages 237-247
Cell therapy products, regenerative medicines, represents a new paradigm in human health, with the possibility of treating many diseases including resolution of unmet medical uses. In order to accelerate the development of the regenerative medicines, several guidelines addressed the safety and efficacy of regenerative medicine have been published. In addition of publication of guidelines, the Act on the Safety of Regenerative Medicine and the Revised Pharmaceutical Affairs Law have recently been simultaneously passed by the Japanese Diet. According to the revised law, a conditional, time-limited marketing authorization will be applied to the regenerative medicine. In this paper, the issues concerning to new legal framework of regenerative medicine will be discussed.
