Drug Evaluation Committee Questionnaire on Post-Marketing Database Surveillance (Feasibility Study/Reliability Confirmation) Report
Pharmacovigilance Subcommittee
July 2024
More than five years have passed since the post-marketing database survey became law, and various studies have been conducted to further develop the utilization of real-world data, with "promotion of post-marketing safety measures using databases" being discussed in the "Pharmaceutical Manufacturers Association of Japan Policy Proposal 2023".
Under these circumstances, KT-6 (KT-6), the Pharmacovigilance Subcommittee of the Drug Evaluation Committee of the Japan Pharmaceutical Manufacturers Association (JPMA), is working to organize issues and to ensure that more useful information obtained from the utilization of real-world data reaches patients through the appropriate implementation of numerous post-marketing database surveys. The KT-6 team is working to organize issues and conduct a large number of appropriate post-marketing database surveys.
Although various notices have been issued on post-marketing database surveys, specific procedures and flows have not been clearly described, and companies are still conducting DB surveys in a state of exploration.
KT-6 is working to standardize each procedure and flow, and as part of such activities, it has established the "Feasibility Study at the Time of DB Selection and Reliability Assessment at the Time of DB Selection". As part of these activities, we conducted a questionnaire survey on "Feasibility Study and Reliability Confirmation at the Time of DB Selection" in order to collect and summarize the experiences of each company. We hope that the results of the questionnaire will be of some help to you when you consider the implementation of a post-marketing database.
Japan Pharmaceutical Manufacturers Association, Committee on Drug Evaluation
Pharmacovigilance Subcommittee, Ongoing Issues Response Team 6
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