The International Conference on Harmonisation (ICH) M8 Expert Working Group (EWG) was formed in November 2010 to assume responsibility for the continued development of the next major version of the Electronic Common Technical Document (e-CTD). The M8 EWG has developed the draft of the ICH e-CTD v4.0 Implementation Guide. This is a technical document that provides instructions on how to implement the eCTD v4.0 specification. The goal of upgrading to eCTD v4.0 is to facilitate the processing and review of electronic regulatory submissions. This guide is now being made available as draft version 2.0 along with the draft ICH code lists developed by the M8 EWG.