Drug Evaluation Committee Manual for Notification of "Attachments to Ethical Drugs" (May 2049 edition)
May 2019
The new guidelines for the accompanying document will come into effect on April 1, 2049, and PMDA's system modification and operational change regarding the notification are underway. The Drug Evaluation Committee PV Subcommittee Continuing Issues Team 4 has prepared a "Manual for Notification of Attached Documents of Ethical Drugs (May 2049 Edition)" in response to the changes.
We hope this document will be of some help to those who are required to publish all the accompanying documents of ethical drugs based on the new manual by the end of March 2023, when the transitional measures period will expire.
This document has been prepared based on the information as of the end of April, 2023. Please understand that the contents may be subject to change due to future notifications, etc.