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

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.

<b>1．The Achievements and Future Directions of MIHARI Project </b> / 薬剤疫学

PMDA, the Japanese regulatory agency, has worked for reinforcing and enhancing its post-marketing safety measures as stated in the second mid-term (FY 2009-2013) plan. MIHARI Project-Medical Information for Risk Assessment Initiative was started in FY 2009 to develop a new safety assessment system for post-marketing drugs using Japanese electronic healthcare data in PMDA. In the second mid-term, we examined characteristics of some electronic healthcare data available in Japan including, claims data, hospital information system data and Diagnosis Procedure Combination (DPC) data in order to make efficient use of those databases for the purpose of drug safety assessment. In addition, some pilot pharmacoepidemiological studies for risk assessment and drug utilization were conducted by use of these electronic healthcare data. Based on the accumulated findings, knowledge, and experiences from the pilot studies, we established the framework by FY 2013 to implement pharmacoepidemiology-based safety assessment in PMDA. In the third mid-term (FY 2014-2018), one of the important mission is to apply this framework into the current risk management process of drug safety. For that purpose, cooperation with other divisions of PMDA such as Office of Safety and Office of New Drug is a key. Simultaneously, we will work to establish an access to another database and novel pharmacoepidemiological methods using electronic healthcare data. A large-scale electronic health record database (MID-NET) as well as national claims database are expected to be an important database in the future activities of MIHARI Project. Furthermore, in April 2015, PMDA established new office focusing on Medical Informatics and Epidemiology for further promotion of electronic healthcare data utilization in Japan. In this article, we describe history and past activities of MIHARI Project followed by future challenges.