2. Japanese Pharmaceutical Regulation's Paradigm Shift to Real-world Data Utilization in Pharmacovigilance / 薬剤疫学

ABSTRACT

In these days, Japanese regulatory reform toward Real World Data (RWD) utilization in Pharmacovigilance (PV) has been carried out. One of the major changes is the amendment of “Ministerial Ordinance on Good Post-marketing Study Practice for Drugs” (No. 171, Ministry of Health, Labour and Welfare, dated December 20, 2004) implemented in April 2018. In this amendment, it clearly defines “Post-marketing database study” as one of post-marketing studies conducted by pharmaceutical companies. However, it does not mean that conventional post-marketing studies (e.g.；enrolling a few thousands patients in a single cohort study with primary data collection), can be simply replaced by the “Post-marketing database study” . The RWD utilization could be a trigger to accelerate efforts on pharmacovigilance in Japan for selecting the best method based on the issue to be addressed.