Consideration of and expectations for the Pharmaceuticals, Medical Devices and Other Therapeutic Products Act in Japan

The Japanese regulatory framework for pharmaceuticals and medical devices has recently been reexamined and the revised Pharmaceutical Affairs Law, which has been renamed the Pharmaceuticals, Medical Devices and Other Therapeutic Products Act, was developed in 2013 and implemented in November 2014. In the revised Act, regenerative medical products are newly categorized and independent from conventional pharmaceuticals and medical devices. This enables these products to be reviewed more appropriately and allows for conditional/time-limited marketing authorization. Following the implementation of the new Act, the Good, Gene Cell and Tissue Manufacturing Practice was established to address the different requirements and concepts for appropriate research and development of regenerative medical products. Based on these changes to the regulatory framework for regenerative medical products in Japan, this article aims to examine how this framework could be utilized as an appropriate system to develop innovative regenerative medicine.