Drug Evaluation Committee
Guidance for Providing Information on "Electronic Drug Information Sheet for Prescription Drugs" (February 2024 Edition)
Pharmacovigilance Subcommittee
February 2024
Manufacturers and distributors are required to promptly and accurately provide information on the proper use of pharmaceuticals to pharmaceutical professionals in order to ensure the efficacy and safety of pharmaceutical products. The "Guideline for Providing Emergency Safety Information" was partially revised in August 2023, and the Drug Evaluation Committee PV Subcommittee Continuing Issues Team 4 has revised the "Guideline for Providing Information on Electronic Attachments of Ethical Drugs" in order to inform the public of the latest procedures and ideas for providing information at the time of revision of electronic attachments. Revision of the Guidance for Provision of Information.
We hope that this guide will be useful in providing appropriate information, including new responses, to pharmaceutical professionals.
Japan Pharmaceutical Manufacturers Association Drug Evaluation Committee
PV Subcommittee Continuing Issues Team 4