Drug Evaluation Committee Examination of Issues for Ensuring Reliability of Post-Marketing Database Surveys
Pharmacovigilance Subcommittee
June 2022
The JPMA has conducted activities aimed at identifying and organizing reliability assurance issues and clarifying necessary actions as operational issues in planning and conducting DB surveys based on pharmacoepidemiology.
This document identifies and summarizes issues for ensuring reliability as operational problems in the planning and implementation of 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 planning high-quality safety surveillance activities and drug risk management plans that will benefit patients.
Japan Pharmaceutical Manufacturers Association Drug Evaluation Committee
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)