ICH M8 Electronic common technical document (eCTD) v4.0 draft ICH implementation guide v2.0 - Scientific guideline

This draft document provides instructions on how to implement the eCTD v4.0 specification. It describes the way files should be constructed for inclusion in the eCTD. Read together with  ICH guideline M8 on eCTD – questions and answers - Step 5.

Keywords: Electronic common technical documentelectronic common technical document (eCTD), eCTD v4.0 specification

Current effective version

International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) on electronic common technical document v4.0 draft ICH implementation guide v2.0 - Step 2

Draft: consultation closedConsultation dates: 03/03/2015 to 22/05/2015Reference Number: EMA/CHMP/ICH/143002/2015 Rev. 1Summary:

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 (eCTD). The M8 EWG has developed the draft of the ICH eCTD 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.