For pharmacovigilance, the Pharmaceuticals and Medical Devices Agency in Japan has utilized real world data (RWD) from multiple sources, including individual case safety reports, and medical information databases that capture routinely collected data from clinical practice. These RWD have their own characteristics with advantages and disadvantages. In this commentary, we describe current and future direction of post-marketing drug safety assessment in Japan.
Waki et al. (Fri,) studied this question.