Drug Evaluation Committee Guidelines for Conducting Post-Marketing Database Surveys - November 2025 Edition -
November 2025
In post-marketing database surveys, if the data necessary for analysis has already been accumulated in a medical information database or registry, unlike post-marketing surveillance using survey forms, there is no need to collect patient-level information on a case-by-case basis. This is expected to lead to more efficient drug safety monitoring in terms of time, cost, and human resources required for the analysis.Furthermore, since it is possible to compare the incidence rates of target events with those of similar drugs with equivalent efficacy, it becomes possible to determine whether the occurrence of a given event is due to the drug or the underlying disease.
On the other hand, while there are various medical information databases that can be utilized for post-marketing database surveys, each has its own characteristics and limitations. Therefore, it is necessary to understand these characteristics and limitations, select a reliable medical information database or registry appropriate for the specific purpose, and formulate and implement a plan accordingly.
Although post-marketing database studies have not yet become widely established as an additional pharmaceutical safety monitoring activity in Japan, there are already products for which re-examination applications have been completed. It is expected that post-marketing database studies will increasingly be selected as an additional pharmaceutical safety monitoring activity in the future, leading to the accumulation of case examples.
In light of the above background, this document, “Guidelines for Conducting Post-Marketing Database Surveys—November 2025 Edition,” has been prepared with the aim of further promoting post-marketing database surveys. In this document, we have endeavored to provide an explanation of the procedures for conducting post-marketing database surveys based on relevant notifications and the experiences of various companies.Furthermore, in preparing this second edition, we have strived to make the content more practical by incorporating the issuance of relevant documents, updates to related notifications, and adding tips derived from the case studies and experiences of various companies. We hope this guide will be of assistance to all companies involved in post-marketing database survey operations in their day-to-day operations and the preparation of documentation.
Japan Pharmaceutical Manufacturers Association, Drug Evaluation Committee
, Pharmacovigilance Subcommittee, Team 6 for Ongoing Issues