Abstract
From pharmacovigilance point of view in Japan, individual case safety reports from industries are important evidence when authorities make decision regarding safety issues, e.g., package insert change. On the other hand, aggregate analysis is not majority due to less infrastructure of available large database than EU/US. Japanese Adverse Drug Event Report database (JADER), which ICSRs have been cumulated, has been tried to use for aggregate analysis. It is not appropriate to use for the purpose of signal management or for primarily deriving safety measures, considering that its source does not cover all the safety information but “spontaneously reported serious adverse reaction”. However, it would be worthwhile to use JADER as a virtual tool to become able to utilize coming large EHR DB and National Claim Database which the authorities have been constructing to be available within few years.
