Recent topics on the utilization of RWD/RWE in the pharmaceutical regulations

Abstract

Recently, the utilization of real world data (RWD) in the development of pharmaceuticals has been discussed. In the Pharmaceuticals and Medical Devices Agency (PMDA), various efforts have been made to promote the utilization of RWD in drug approval applications. Issues related to the utilization of RWD will continue to be discussed. Although the number of drugs using RWD is limited in the application, we hope that the application will continue to be reviewed so that a certain amount of evidence can be constructed from a variety of data in the development of drugs for neurologically diseases.