Regenerative Medicine Database

Regenerative Medicine Database

This module is involved in building the National Regenerative Medicine Database (NRMD) – a collection of case databases covering all phases of regenerative medicine, from clinical research (NRMD/CR) to post-marketing studies (NRMD/PMS).

 

Data registration items common to disease areas have been created in partnership with PMDA. Additional data registration items for specific disease fields have been determined through comprehensive discussions with related academic societies. Management of  registered data meets high-level Computerized System Validation (CSV) standards, fulfilling the requirements of the Ministerial Ordinance on GPSP.

 

This collection of databases will make it easier to utilize clinical data in accordance with the Pharmaceuticals and Medical Devices Act. It will also allow researchers to build reliable, high-quality data sets, even for clinical research that is not required to meet the standards stipulated in the relevant pharmaceutical regulatory guidelines. The NRMD is compliant with Clinical Data Interchange Standards Consortium (CDISC) standards, opening up possibilities for the flexible use of this data in future international research and development projects.

 

High quality PMS plays an extremely important role in approval of regenerative medicine-related products, especially for products with conditional, time-limited approval which require comprehensive confirmation of effectiveness after being put on sale.

 

In response to this situation, the Ministry of Health, Labour, and Welfare (MHLW) issued a Notification from the Director of the Pharmaceutical Safety Division of the Pharmaceutical Safety and Environmental Health Bureau, dated September 28, 2017, entitled “Patient Registration System for Regenerative Medical Products (Request for Cooperation.)” The creation of the NRMD has been well received by related government authorities, as indicated by the inclusion of a recommendation for post-market surveys of regenerative medicine products using NRMD/PMS in this Notification.

 

Overview of the National Regenerative Medicine Database (NRMD)