Drug Evaluation Committee Tips for Signal Management Activities in Japan
Pharmacovigilance Subcommittee
August 2025
This White Book provides an overview of the signal management activities of regulatory authorities in Japan, the U.S., and Europe, as well as the basic approach to signal management based on the activities of these regulatory authorities and others. The White Book is intended to provide an overview of regulatory signal management activities in Japan, the U.S., and Europe, as well as basic signal management practices based on these regulatory activities. We hope that this White Book will be of assistance to Japanese companies in establishing their own signal management procedures.
Japan Pharmaceutical Manufacturers Association, Committee on Drug Evaluation
Deliverables of the Drug Evaluation Committee Return to list of all deliverables