Drug Evaluation Committee Establishing Safety Considerations and Research Questions (Research Questions) for Scientific Drug Risk Management Planning (RMP) Practices (August 2014)
August 2014
The Data Science Subcommittee of the Drug Evaluation Committee’s FY2013 Task Force 1 compiled a set of safety considerations and research questions for the practical implementation of scientific Risk Management Plans (RMPs) for pharmaceuticals.
Now that the RMP has been fully implemented, we believe that pharmaceutical risk management should go beyond the framework of traditional post-marketing surveillance—which does not establish a control group—by considering countermeasures on a case-by-case basis, conducting truly necessary research, and evaluating the results.
While conventional post-marketing surveillance studies have many regulatory and operational issues, from a scientific perspective, the “research questions” for these studies are often ambiguous.Therefore, this task force, without being bound by Japan’s unique practices, based its discussions on fundamental principles and theoretical ideals, focusing primarily on “what is necessary to clarify the research questions of the studies” and “designing studies tailored to individual research questions.”
This report is intended for personnel involved in approval applications (those responsible for development, statistics, safety, and post-marketing surveillance) and outlines the necessary approach for developing individual countermeasures based on safety considerations.
We hope this report will serve as a catalyst for “Kaizen” in RMPs.