Drug Evaluation Committee Points to keep in mind when conducting post-marketing database surveys of pharmaceuticals using medical information databases, etc.
December 2020
Following the April 2018 amendment to the GPSP Ministerial Ordinance, post-marketing database studies can now be selected as an additional safety monitoring activity, and related guidelines have been issued.Conducting post-marketing database studies requires not only knowledge of pharmacoepidemiology but also an understanding of the Pharmaceutical Risk Management Plan (RMP) and the re-evaluation system, as well as relevant regulations and quality assurance; this presents practical challenges in implementation.
The Data Science Subcommittee formed a task force team to compile procedures and key considerations for practitioners involved in post-marketing database studies of pharmaceuticals. This document introduces the relevant regulations and guidance that must be understood when conducting such studies.
We hope this document will be used to acquire basic knowledge regarding post-marketing database studies, so that readers can correctly understand the benefits and limitations of such studies, select the scientifically optimal methods according to the study objectives, identify the most appropriate data sources for their research questions, and plan and conduct efficient and effective studies.
Japan Pharmaceutical Manufacturers Association, Drug Evaluation Committee, Data Science Subcommittee
FY2018 Task Force 7: Data Management in Observational Studies
Post-Marketing Database Research Team