Operational Improvement of Investigational Committee on Relief Services for Adverse Health Events in Pharmaceuticals and Medical Devices Agency (PMDA), Japan―Present and Future―

Abstract

Investigational Committee on Relief Services for Adverse Health Events in Pharmaceutical and Medical Devices Agency (PMDA) was herein introduced and the attempts for operational improvements of this committee were shown. Questionnaires were newly performed among patients and their family members who received payment decision notices for the last three years from PMDA. Their results were summarized and critically analyzed here. The committee has also been performed the hearing from one of the top investigators in this field. Based on the discussion among the committee members, we therefore created a new report of this committee to improve Relief Services for Adverse Health Events in PMDA. The summary of this report was demonstrated and potential problems were also discussed.