प्रत्यारोपण प्रौद्योगिकी एवं अनुसंधान

A New National Framework for Clinical Trials and Evaluation of Innovative Medical Care Technologies Using Living Cell Transplantation in Japan

Abstract

Kiyoshi Okada

Following the global initiative to develop medical innovative technologies such as living cell transplantation, the Japanese promotion plan, “Five-year Clinical Trial Vitalization Plan 2012” was launched in 2012. Subsequently, “Clinical Trials Core Hospitals” or medical care institutions that performed research and development of innovative technologies were identified, which were regularly evaluated by the “Evaluation System for Investigational Medical Care.” In addition, the regulatory guidelines for pharmaceuticals and medical devices 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), and the Act on the safety of regenerative medicine were developed in 2013 and is scheduled for implementation in November 2014. Based on these changes in the national framework for innovative medical care in Japan, this article aims to explain and evaluate the possibility for this framework to be utilized as the universal case model for stem cell and living cell transplantation.