Introduction

My name is Minoru Shimodera, and I have spent many years in a global pharmaceutical company leading post-marketing pharmacovigilance (PV) activities, post-marketing database study, and pharmacoepidemiology initiatives. As for my roles in supporting the industry’s effort, I have also been a member of working groups discussing MHLW/PMDA notifications and guidance regarding post-marketing database studies. In this series of column articles, I would like to share practical insights based on these experiences, particularly how to correctly interpret the notifications and administrative letters issued by the Japanese Ministry of Health, Labour and Welfare (MHLW). Simply put, my goal is to clarify the interpretation and practical implementation of PMDA-aligned post-marketing database study guidance.

We are now entering the eighth year following the introduction of post-marketing database studies. While many notifications and administrative communications have since been issued, w...