Electronic Common Technical Document (eCTD) v4.0
For Implementation Planning ONLY
The following documentation, files, and links 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 plan to accept new applications in eCTD v4.0 format in 2024. Future implementation phases will address existing v3.2.2 applications and two-way communication.
Latest Update
ICH M8 and FDA have split their respective Implementation Packages to enable Controlled Vocabulary Versioning:
- ICH eCTD v4.0 Implementation Guide Package (which contains the ICH eCTD v4.0 Implementation Guide, Package History, and Schema Files)
- ICH eCTD v4.0 Controlled Vocabulary Package (which contains the ICH Code List and Genericode Files)
ICH Call for Vendor Participation
If you are an eCTD v4.0 Tool Vendor and would like to join the eCTD Tool Vendor Group to discuss eCTD v4.0 implementation, see the ICH eCTD v4.0 page for information on how to join.
For information on ICH implementations, refer to the Regional Implementation Information section on the ICH eCTD v4.0 page.
eCTD v4.0 Documents and Files
Technical Conformance Guide
The eCTD v4.0 Technical Conformance Guide (v1.3) provides specifications, recommendations, and general considerations on how to submit eCTD v4.0-based electronic submissions to CDER or CBER.
Download Technical Conformance Guide
Module 1 Implementation Guide
The FDA eCTD v4.0 Module 1 Implementation Guide (v1.7) provides instructions on how to implement the eCTD v4.0 specification for the FDA Module 1 submission content.
Download Module 1 Implementation Guide
Controlled Vocabulary Package
The FDA eCTD v4.0 Controlled Vocabulary Package (v1.0) contains the information for the controlled vocabulary files needed to implement eCTD v4.0. It includes the FDA eCTD v4.0 Controlled Vocabulary Code List and the FDA Genericode Files.
Download Controlled Vocabulary Package
Samples Package
The FDA eCTD v4.0 Samples Package includes sample files and a samples history with notes for the changes made in this version of the package.
Validation Specifications
The eCTD v4.0 Validation Specifications (v1.3) detail the validation criteria applied when FDA processes eCTD v4.0 submissions.
Download Validation Specifications
Comprehensive Table of Contents Headings and Hierarchy
This document (v2.0) provides instructions on how the reader may be presented eCTD content in a viewing or display tool.
Additional Resources
ICH 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, see the Change Control section on the ICH eCTD v4.0 page.