Drug Evaluation Committee How to proceed with the study of post-marketing database survey using the registry -February 2025 edition- (in Japanese)
Pharmacovigilance Subcommittee
March 2025
Post-marketing database surveys (post-marketing DB surveys) are being planned at a certain rate, and studies in the new environment are becoming established. Despite the fact that registries are targeted as data used in post-marketing DB surveys in addition to medical information databases, their utilization is still limited.
The Pharmacovigilance Subcommittee's Team 6 for Ongoing Issues summarized the main points to be considered in the post-marketing DB survey using registry data, from the establishment of a relationship with the registry holder to the start of the survey, based on interviews with companies with experience in registry utilization within the team.
While experience in registry utilization is still limited, we hope that this document, "How to Proceed with Post-Marketing Database Surveys Using Registries," will help to broaden the options for those in charge of companies that are actually considering post-marketing database surveys using registry data.
Japan Pharmaceutical Manufacturers Association, Committee on Drug Evaluation
Pharmacovigilance Subcommittee, Ongoing Issues Response Team 6
Deliverables of the Drug Evaluation Committee Return to list of all deliverables