The ICH M8 EWG was formed in November 2010 to assume responsibility for the continued development of the next major version of the eCTD. The M8 EWG has developed the draft of the ICH eCTD v4.0 Implementation Guide. This guide is now being made available as DRAFT Version 2.0 along with the draft ICH Code Lists developed by the M8 EWG.

At the November 2014 ICH meeting, the ICH Steering Committee endorsed the M8 EWG to post the ICH eCTD v4.0 DRAFT Implementation Guide v2.0 and related files for regulatory consultation until May 22, 2015.

http://estri.ich.org/new-eCTD/index.htm

http://estri.ich.org/new-eCTD/ICH_eCTDv4_0_Step2_Packagev2_0.zip