As definitions of real-world data (RWD) and real-world evidence (RWE) are not standardized, the PhRMA Japan Medical Affairs Committee Working Group 1 reviewed these definitions from the perspectives of clinical development and medical affairs in Japan and propose that RWD is defined as “data relating to patient health status and/or delivery of health care routinely collected from a variety of sources” and RWE as “evidence derived from analysis of RWD.”

In Japan, challenges exist around access and linkage of RWD, as well as a lack of universally accepted methodological approaches, which reduces the potential for patient and healthcare benefits.

Improvements in RWD access and database linkage will enable both public and private sectors to assemble more comprehensive health information in Japan.