Abstract
In 2013, the Japanese Diet passed the Regenerative Medicine Promotion Act and the Act Regarding Ensuring Safety of Regenerative Medicine (the "Regenerative Medicine Safety Act"), as well as the revisions to the Pharmaceutical Affairs Act (new PAA). One of the aims of the new/revised Acts is to promote the development and translation of and access to regenerative/cellular therapies. In the new PAA, a cell-processed product for regenerative/cellular therapy is defined as a "regenerative medical product", a product distinct from pharmaceuticals and medical devices, allowing regenerative medical products to obtain a conditional and time-limited marketing authorization much earlier than that under the conventional system. The Regenerative Medicine Safety Act enables medical institutions/hospitals to outsource cell processing to companies. This minireview provides perspectives on the new regulatory framework and scientific hurdles for translation of regenerative/cellular therapies.
