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# ICH Adoption Phase for eCTD v4.0 Guideline
- URL: https://www.fdaweb.com/ich-adoption-phase-for-ectd-v4-0-guideline/
- Published: 2016-03-31T12:00:00.000Z
- Updated: 2026-09-14T20:52:03.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5135240

> The International Council on Harmonization (ICH) has reached the adoption phase (Step 4) on an Electronic Common Technical Document v4.0 Implementation Package for Modules 2 through 5\. Step 4 enables each regulatory region to start the implementation process. As part of the implementation process, FDA says it is providing the eCTD v4.0 Module 1 Implementation Package for planning purposes only. Both the ICH and FDA Implementation Packages are technical instructions on how to implement the eCTD v4.0 specification ([download the FDA eCTD v4.0 Module 1 Implementation Package](http://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/FormsSubmissionRequirements/ElectronicSubmissions/UCM439879.zip?ref=fdaweb.com)\-.zip file).