Drug Evaluation Committee
Results of Questionnaire on Information Provision Activities at the Time of the Revision of "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 PV Subcommittee of the Drug Evaluation Committee has conducted a questionnaire survey and interviews on the procedures and internal systems of each company about one year after the revision, and compiled the results. 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 the pharmaceutical community.
Japan Pharmaceutical Manufacturers Association, Committee on Drug Evaluation
PV Subcommittee, Continuing Issues Team 4
Deliverables of the Drug Evaluation Committee Return to list of all deliverables