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  6. Electronic Common Technical Document (eCTD) v4.0
  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

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).

FDA eCTD v4.0 Implementation Status

CDER and CBER are in the process of testing our eCTD v4.0 software and coordinating with our industry technical pilot participants to perform eCTD v4.0 submission testing in 2022.

CDER and CBER plan to accept new applications in eCTD v4.0 format in 2023. Future implementation phases will address transition of v3.2.2 applications and two-way communication.

For information on ICH implementations please refer to the Regional Implementation Information section on the ICH eCTD v4.0 webpage.

eCTD v4.0 Technical Conformance Guide

Download eCTD v4.0 Technical Conformance Guide (PDF)

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)

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)

Information required to validate an eCTD v4.0 submission.

eCTD v4.0 Comprehensive Table of Contents Headings and Hierarchy

Download eCTD v4.0 Comprehensive Table of Contents Headings and Hierarchy (PDF - 1MB)

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

The ICH eCTD v4.0 Implementation Package, regional Implementation timeline information, 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.

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