Drug Evaluation Committee Guidance for preparation of "electronic package inserts for ethical drugs" -Corresponding to the guideline for preparation of electronic package inserts in 2009 and 2021 - (April 2022 edition)
April 2022
The Drug Evaluation Committee PV Subcommittee Continuing Issues Team 4 has prepared a "Guide for Preparation of Electronic Attached Documents for Prescription Drugs: Compliance with the Guidelines for Description in 2009 and 2021 (April 2022 edition)".
In addition, we have updated the information related to the computerization of accompanying documents in accordance with the revised Pharmaceutical Affairs Law that came into effect on August 1, 2021, and have added "Guidelines for the Description of Electronic Attached Documents of Ethical Drugs" (April 2022 edition). (Notification of the Director-General of the Pharmaceuticals and Medical Devices Bureau of the Ministry of Health, Labour and Welfare No. 0611-1 dated June 11, 2021).
Please make use of this notice to prepare the attached document in electronic format in compliance with the guidelines of 2009 and 2021.
Japan Pharmaceutical Manufacturers Association Drug Evaluation Committee
PV Subcommittee 2021 Ongoing Issues Team 4