Regulatory frameworks for cell therapy products in Japan.

This paper reviews regulatory frameworks for cell therapy products in Japan. Two procedures are used to investigate the use of new cell therapy products in Japan. One is to perform clinical trials in accordance with the provisions of the Pharmaceuticals Affairs Act (PAA); the other is to perform clinical research in accordance with the provisions of the Medical Practitioners Act. For full commercialization of medical products in Japan, we must consider the universal health care system. All medical products used to treat patients in the system must be approved, in accordance with the provisions of the PAA, as drugs or medical devices. Thus, researchers in academia who have developed new cell therapy products should consider performing clinical trials in accordance with the provisions of the PAA to test their products clinically. This article describes development and review processes for new drug/device applications in accordance with the provisions of the PAA and gives an example of clinical review of a cell therapy product by the Pharmaceuticals and Medical Devices Agency.