Current status of the regulation and development of cell therapy products in Japan

Abstract

Ten years have passed since Yamanaka et al. reported the establishment of human iPS cells, which became one of the triggers to make national efforts in Japan to promote research and translation of regenerative medicine and cell therapy (regenerative medicine etc.). However, it has been unreasonable in many cases to directly apply the existing regulation to cells processed for the purpose of use in regenerative medicine etc., which have quite different properties from conventional pharmaceuticals and medical devices. For this reason, in recent years, drastic reforms of various regulations of medical and pharmaceutical affairs have been vigorously pursued for efficient translation of regenerative medicine etc. Regarding medical affairs, "The Act on the Safety of Regenerative Medicine" was established for the purpose of providing safe regenerative medicine etc. to patients promptly and smoothly, establishing standards for regenerative medicine providing agencies and cell culture processing facilities. Regarding pharmaceutical affairs, a new chapter and an early approval system (conditional/term-limited approval system) for "regenerative medical products", which consists of cellular and gene therapy products, were introduced into "Pharmaceuticals and Medical Devices Act", a revised and renamed version of "Pharmaceutical Affairs Law". In this review article, we overview the current perspectives of regulations and challenges for translation of regenerative medicine etc. in Japan.