Drug Evaluation Committee
Results of Questionnaire on Information Provision Activities at the Time of the Revision of the "Precautions for Use
-Trend of each company after the revision of the guidelines for safety and efficacy
Pharmacovigilance Subcommittee
December 2025
In order to ensure the efficacy and safety of pharmaceutical products, manufacturers and distributors are required to promptly and accurately provide information on the proper use of pharmaceutical products to the medical community.
Following the partial revision in August 2023 of the "Guidelines for the Provision of Emergency Safety Information", which serves as a guideline for this purpose, companies have been reviewing their procedures and approaches for information provision activities at the time of the revision of electronic supplementary information.
The Drug Evaluation Committee's PV Subcommittee Continuing Issues Team 4 has compiled the results of a questionnaire survey and hearings on the procedures and internal systems of each company to be followed approximately one year after the revision. We hope that this information will be useful to companies in establishing their own systems and procedures for the effective and appropriate provision of information to pharmaceutical professionals.
Japan Pharmaceutical Manufacturers Association Drug Evaluation Committee
PV Subcommittee Continuing Issues Team 4