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  1. Electronic Regulatory Submission and Review

Electronic Common Technical Document (eCTD) v4.0

The documents and files referenced on this web page are: FOR IMPLEMENTATION PLANNING ONLY

 

Electronic Common Technical Document (eCTD) v4.0 Technical Conformance Guide; FDA eCTD v4.0 Module 1 Implementation Package;

The Food and Drug Administration (FDA) is reviewing 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. Please refer to the Federal Register Notice to review the comments.

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.

Additional Resources: ICH eCTD v4.0 Step 4 – Implementation Package

The ICH eCTD v4.0 Implementation Package and related files are available for download from  the ICH eCTD v4.0 Step 4 page [External Link Disclaimer].

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.

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