ICH Project Briefing on eCTD v4.0 (ICH M8) Notification Amendment and Operationalization
Feb 04, 2022
Based on the guidelines that reached Step 4 agreement at 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. After the revision of the Implementation Guide, the eCTD v4.0 acceptance start date is now approaching.
In order to ensure the smooth implementation of eCTD v4.0, a briefing session on eCTD v4.0 will be held on Friday, March 11, 2022, jointly with the Ministry of Health, Labor and Welfare and the Japan Pharmaceutical Manufacturers Association (JPMA).
The program and other details of the briefing can be found on the PMDA Website.
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