Revision to the authorization system for regenerative medicine products
NRMD is an integrated public-private sector database developed jointly with PMDA and operated with the cooperation of The Japanese Medical Science Federation. The Pharmaceuticals and Medical Devices Act (PMD Act) enacted in November 2014 revised the authorization system for regenerative medical and related products in order to achieve rapid practical application. Under this system, the efficacy of regenerative medical or related products is estimated and if their safety is recognized, products are granted special, rapid authorization with conditions and a time limit attached (conditional/time-limited authorization), widening the possibility for accelerated practical application.
Collection and evaluation of PMS data is key
Under this conditional/time-limited authorization system, a product's efficacy is estimated in a short time frame based on a limited number of cases, allowing safety to be evaluated on a short time schedule, such as acute side effects. However, due to reasons including product non-uniformity, manufacturing capacity, and applicable patient numbers, restrictions have been placed on collection and evaluation of clinical data. Accordingly, collaboration with affiliated societies and other organizations is required in order to design sound safety plans and steady collection and evaluation of data.
MHLW advocates R&D models that utilize NRMD
Japan's Ministry of Health, Labour and Welfare (MHLW) has advocated an R&D model for regenerative medicine and related products that utilizes JSRM's NRMD system to steadily collect and evaluate PMS data, with a notification issued by the head of the director of Pharmaceutical Safety Division, Pharmaceutical Safety and Environmental Health Bureau, MHLW, requesting that NRMD be used in PMS of such products.
(PSEHB/PSD Notification No. 0928-1, September 28, 2017)