Drug Evaluation Committee Examination of Issues for Ensuring Reliability of Post-Marketing Database Surveillance
Pharmacovigilance Subcommittee
June 2022
The committee conducted activities aimed at identifying and organizing issues for ensuring reliability and clarifying necessary actions as operational issues in the planning and implementation of pharmacoepidemiology-based DB surveys.
This document identifies and summarizes the issues of ensuring reliability as operational problems in planning and implementing DB surveys based on pharmacoepidemiology from the perspective of pharmaceutical companies. In addition, based on the opinions and information obtained through the activities to identify and organize reliability assurance issues and to clarify necessary actions, we proposed the efficiency improvement of reliability assurance and collaboration with DB operators as an approach to solve the issues.
We hope that this document will be useful for sufficient discussion on reliability assurance between PMDA and pharmaceutical companies and for the creation of a "DB survey management tool," and that it will ultimately assist in developing high-quality safety surveillance activities and drug risk management plans that will benefit patients.
Drug Evaluation Committee, Japan Pharmaceutical Manufacturers Association
PV Subcommittee Continuing Issues Team 6
Examination of issues to ensure reliability of post-marketing database survey (1.4MB)
Appendix "Summary of Results of Questionnaire on Reliability Consultation" (January 5, 2022) (993KB)
Deliverables of the Drug Evaluation Committee Return to list of all deliverables