Drug Evaluation Committee Points to keep in mind when conducting post-marketing database survey of pharmaceuticals using medical information databases, etc.
Data Science Subcommittee
December 2020
With the April 2018 revision of the GPSP Ordinance, post-marketing database investigations can now be selected as an additional safety surveillance activity, and related guidelines have been issued. Conducting a post-marketing database survey requires not only knowledge of pharmacoepidemiology, but also knowledge of the series of drug risk management plans (RMPs) and reexamination systems, related regulations, and quality assurance, making it difficult to implement in practice.
The Data Science Subcommittee formed a task force team to summarize the procedures and considerations for those who will be involved in post-marketing database surveillance of pharmaceuticals, while introducing relevant regulations and guidance that should be known when conducting a post-marketing database surveillance of pharmaceuticals.
We hope that this document will help you gain a basic knowledge of post-marketing database surveys so that you can properly understand the merits and limitations of database surveys, select the scientifically most appropriate method according to the purpose of the survey, identify the best data source for the research question, and plan and conduct the survey efficiently and effectively. We hope that you will use this document to gain basic knowledge of post-marketing database surveys.
Japan Pharmaceutical Manufacturers Association, Committee on Drug Evaluation, Data Science Subcommittee
2018 Task Force 7 Data Management in Observational Studies
Post-Marketing Database Survey Team
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