Drug Evaluation Committee
Guidance for providing information on "electronic package inserts for ethical drugs" (February 2024 edition)
Pharmacovigilance Subcommittee
February 2024
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 pharmaceutical professionals. The "Guideline for Provision of Emergency Safety Information" was partially revised in August 2023, and for the purpose of informing the public of the latest procedures and ideas for providing information at the time of revision of the electronic package insert, the Drug Evaluation Committee PV Subcommittee Continuing Issues Response Team 4 has revised the "Guideline for Provision of Information on Electronic Attached Documents of Ethical Drugs" (the "Guideline"). Revision of the Guidance for Provision of Information.
We hope that this guide will be of use in providing appropriate information, including new responses, to pharmaceutical professionals.
Japan Pharmaceutical Manufacturers Association, Committee on Drug Evaluation
PV Subcommittee, Continuing Issues Team 4
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