Drug Evaluation Committee Guidance for Conducting Post-Marketing Database Surveillance -November 2025 Edition-.
Pharmacovigilance Subcommittee
November 2025
In a post-marketing database survey, if the data necessary for the review have already been accumulated in a medical information database or registry, unlike a use-results survey using a questionnaire, it is not necessary to collect information for each patient on a case-by-case basis, which is expected to lead to more efficient drug safety monitoring in terms of time, cost, and human resources required for the review. This is expected to lead to more efficient drug safety surveillance in terms of time, cost, and human resources. In addition, since the frequency of occurrence of the targeted event can be compared with that of the same drug, it is possible to consider whether the occurrence of the event is caused by the drug or the underlying disease.
On the other hand, medical information DBs utilized in the post-marketing DB survey include DBs that accumulate various types of medical information, each with different characteristics and limitations. Therefore, after understanding the characteristics and limitations of each DB, a reliable medical information DB or registry should be selected according to the purpose, and an appropriate plan should be formulated and implemented.
In Japan, post-marketing surveillance as an additional drug safety surveillance activity has not yet become widespread and established, but some items have already been submitted for reexamination, and it is expected that post-marketing surveillance will be selected as an additional drug safety surveillance activity and more cases will be accumulated in the future. In light of the above, the Post-Marketing Drug Safety Monitoring (PSDM) is a new approach to drug safety surveillance.
In light of the above, we have prepared this document, "Guidance for Conducting Post-Marketing Database Surveillance - November 2025 Edition," for the purpose of further promoting post-marketing database surveillance. In this document, we have tried to explain the procedures for conducting post-marketing database surveys based on relevant notifications and the experience of each company. In preparing the second edition, we have tried to make the contents more practical by reflecting the issuance of related documents and updates to related notices, as well as by adding tips based on case studies and experiences of each company. We hope that it will be of help to all companies involved in post-marketing DB survey operations in their business operations and in the preparation of documentation.
Japan Pharmaceutical Manufacturers Association, Committee on Drug Evaluation
Pharmacovigilance Subcommittee, Ongoing Issues Response Team 6
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