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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 existing v3.2.2 applications and two-way communication.

UPDATE: ICH M8 has posted eCTD v4.0 Implementation Package v1.5 that includes Forward Compatibility v3.2.2 requirements and replaces the v4.0 Transition Mapping Message. Forward Compatibility enables life cycle and document reuse of v3.2.2 content streamlining the conversion of v3.2.2 applications to eCTD v4.0. FDA has updated our eCTD v4.0 regional documentation to incorporate Forward Compatibility. This will not impact the first phase of FDA v4.0 implementation in 2023, in which only new applications in eCTD v4.0 format will be accepted.

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) (UPDATED September 2022)

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 September 2022)

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.

NOTE: FDA eCTD v4.0 Module 1 Implementation Package v1.5.1 corrects an error in the Promotional Materials sample. No additional modifications were made to the September 2022 FDA eCTD v4.0 Module 1 Implementation Package v1.5 update.

eCTD v4.0 Validation Specifications

Download Specifications for eCTD v4.0 Validation Criteria (PDF - 1 MB) (UPDATED October 2022)

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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