Drug Evaluation Committee Tips for Signal Management Activities in Japan
Pharmacovigilance Subcommittee
August 2025
This white book is intended to provide an overview of the signal management activities of regulatory authorities in Japan, the U.S., and Europe, as well as a basic guide 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.
Drug Evaluation Committee, Japan Pharmaceutical Manufacturers Association