ICH Project Briefing Session on the Revision and Implementation of eCTD v4.0 (ICH M8)
February 4, 2022
Based on the guidelines for which Step 4 consensus was reached by the ICH M8 Expert Working Group (EWG/IWG) in December 2015, the eCTD v4.0 Implementation Guide for Japan was issued as a notification in July 2017.Following revisions to the implementation guide and other developments, the start date for accepting eCTD v4.0 submissions is finally approaching. To ensure a smooth launch of the
system, we will hold a briefing session on the operation of eCTD v4.0 on Friday, March 11, 2022, co-hosted by the Ministry of Health, Labor and Welfare and the Japan Pharmaceutical Manufacturers Association.
Details regarding the program and other information for this briefing session are available on the PMDA website.