Drug Evaluation Committee Guidance for notification of "electronic package inserts for ethical drugs" -April 2026 edition- (Japanese only)
Pharmacovigilance Subcommittee
April 2026
The Japan Pharmaceutical Manufacturers Association Drug Evaluation Committee PV Subcommittee Continuing Issues Response Team 4 has prepared "Guidance for Notification of Electronic Attached Documents for Prescription Drugs - April 2026 Edition", which summarizes the latest operations and practices regarding the "Electronic Attached Documents for Prescription Drugs" notification system. -This guide is the latest operational and practical guide to the "electronic package insert" notification system for prescription pharmaceuticals.
This guide reflects notifications, administrative communications, etc. as of March 31, 2026,
- End of the transitional period for the new guidelines for the attached document
- Handling of collation source data and notification procedures using the PKW site
- Operation of prior consultation
This guide comprehensively outlines how to respond in accordance with the latest system operation, including the following
We hope that this guide will be of wide use to manufacturers and distributors in their practices related to preparation, notification, publication, etc. of electronic attached documents.