The documentation and links on this webpage provide information 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).
eCTD v4.0 Technical Conformance Guide
Provides specifications, recommendations, and general considerations on how to submit eCTD v4.0-based electronic submissions to CDER or CBER.
FDA eCTD v4.0 Module 1 Implementation Package
Download FDA eCTD v4.0 Module 1 Implementation Package (ZIP - 2.5MB) (Updated June 2021)
The FDA eCTD v4.0 Module 1 Implementation Package and the ICH eCTD v4.0 Implementation Package (see Additional Resources) provide the specifications to create and submit eCTD v4.0-based electronic submissions to CDER or CBER.
eCTD v4.0 Validation Specifications
Download Specifications for eCTD v4.0 Validation Criteria (PDF - 1MB) NEW
Information required to validate an eCTD v4.0 submission.
eCTD v4.0 Comprehensive Table of Contents Headings and Hierarchy
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.
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.