Abstract
The Act on the Safety of Regenerative Medicine was passed approved by Japanese Diet in November 2013, and started in 25th November 2014. This Act covers cell therapies those safety and efficacy have not been established and purpose of therapy is classified as one of the followings: (1) technologies intended for reconstruction, repair, or formation of structure or functions of the human body or (2) those intended for treatment or prevention of human diseases by use of processed cells. This act will be applied not only to clinical trials but also cell therapies administered in daily practice outside of national health insurance.Dental regenerative medicine such as platelet-rich plasma for wound healing is also covered by this act. In this review, overview of the Act on the Safety of Regenerative Medicine, and the relationship with dental regenerative medicine are introduced.
