Insurance systems and reimbursement concerning research and development of regenerative medicine in Japan.

In Japan, the Act on the Safety of Regenerative Medicine and the Pharmaceuticals, Medical Devices and Other Therapeutic Products Act were enacted in November 2014, creating a new framework for clinical research and products related to regenerative medicine. Together with these regulatory frameworks, new insurance procedures were created for handling regenerative medicine in Japan. For developing regenerative medicine in Japan, understanding medical insurance greatly influences funding and venture success, particularly in the stages between clinical research and market launch. The study aimed to identify the issues and examples surrounding Japan's present medical insurance system, especially for regenerative medicine. We believe that building stronger insurance systems for regenerative medicine is essential for internationally aligning and harmonizing the progress of regenerative medicine.