Drug Evaluation Committee Comparative Study on the Status of Development of Additional Risk Minimization Activities for Pharmaceutical Risk Management Plans (RMPs) in Japan, the U.S., and Europe
Pharmacovigilance Subcommittee
November 2023
Additional risk minimization activities are planned and developed as part of the pharmaceutical risk management plan. In addition to normal risk minimization activities, additional risk minimization activities are developed as needed, taking into account country/regional regulations, the healthcare environment, and drug-specific factors.
PV Subcommittee KT1 conducted a survey of the status of development of additional risk minimization activities in Europe, the US, and Japan to understand how they have been developed in these countries/regions in recent years. The goal was to understand the status of the development of additional risk minimization activities in Europe, the United States and Japan in recent years.
We hope that this document will be of assistance to those involved in the review and development of additional risk minimization activities.
＜Excerpts from the results
November 2023
Drug Evaluation Committee PV Subcommittee Continuing Issues Response Team 1 (KT1)
Deliverables of the Drug Evaluation Committee Return to list of all deliverables