Drug Evaluation Committee Guidance for preparation of "electronic package inserts for ethical drugs" (revised version as of April 2024)
Pharmacovigilance Subcommittee
April 2024
The Drug Evaluation Committee's PV Subcommittee Continuing Issues Team 4 has prepared "Guidance for Preparation of Electronic Attached Documents for Prescription Drugs (Revised Version as of April 2024). The contents of this document include the addition of special notes regarding the revision of the description guidelines for drugs that have received urgent approval, etc., to the previous guide. In addition, the content of the revised guide has been reflected in the guidance issued in February 2023 regarding the need for contraception in relation to the administration of pharmaceutical products and the revised guide for the results of surveys using medical information databases.
Please make use of this document when preparing electronic package inserts for ethical drugs.
Japan Pharmaceutical Manufacturers Association Drug Evaluation Committee
PV Subcommittee Continuing Issues Team 4