Abstract
The government of Japan made a nation-wide preparedness for innovative regenerative medicine, both research promotion and safety assurance. The regulatory guidelines for regenerative medicine have been reexamined and the revised Pharmaceutical Affairs Law (PAL), which was renamed as the Pharmaceuticals, Medical Devices and Other Therapeutic Products Act (PMD Act), were implemented in Nov. 2014 in Japan. Based on these changes in the national framework for regenerative medicine in Japan, we would like to introduce the past, new and near-future approved regenerative medical products in this framework.
