Electronic Common Technical Document (eCTD) v4.0 Technical Conformance Guide; FDA eCTD v4.0 Module 1 Implementation Package;
The Food and Drug Administration (FDA) has completed the review of public comments received on the draft Electronic Common Technical Document (eCTD) v4.0 Technical Conformance Guide, and the FDA eCTD v4.0 Module 1 Implementation Package. The updated documentation will be used to implement FDA’s eCTD v4.0 functionality. We are working with our software vendor and technical staff to prepare for the implementation of eCTD v4.0.
The eCTD v4.0 Technical Conformance Guide will provide specifications, recommendations, and general considerations on how to submit eCTD v4.0-based electronic submissions to the Center for Drug Evaluation and Research (CDER) or the Center for Biologics Evaluation and Research (CBER) using the ICH eCTD v4.0 Implementation Package and the FDA eCTD v4.0 Module 1 Implementation Package. These versions of the documents are for review and implementation planning purposes only.
- Download the eCTD v4.0 Technical Conformance Guide (PDF)
- Download the FDA eCTD v4.0 Module 1 Implementation Package (ZIP)
Additional Resources: ICH eCTD v4.0 Step 4 – Implementation Package
To submit comments or questions on the ICH eCTD v4.0 Implementation Package please see the Change Control section on the ICH eCTD v4.0 webpage.