eCTD Submission Standards for eCTD v4.0 and Regional M1

CDER and CBER are accepting new regulatory applications in eCTD v4.0 format as of September 16, 2024. More information can be found on the eCTD page.

Future implementation phases will address forward compatibility for existing v3.2.2 applications and two-way communication.

The table below lists all the documents and supportive files applicable to eCTD submissions to CDER and CBER.

• Version History
• Submission Standards for eCTD v4.0
• Validation Tools and Electronic Submission Validation Criteria in Use

Version History

2026

• 8/28/2026 – Updates to FDA Regional CV eCTD v4.0 Package, FDA Regional eCTD v4.0 IG, and Specification for eCTD v4.0 Validation Criteria
• 7/9/2026 – Updates to FDA Regional CV eCTD v4.0 Package; eCTD v4.0 Technical Conformance Guide; Transmission Specifications
  • Added FDA Regional Forward Compatibility XML Samples

2025

• 10/20/2025 – Updates to Specification for eCTD Validation Criteria and FDA Regional eCTD v4.0 Module 1 Implementation Guide
• 8/20/2025 – Updates to Specification for File Format Types Using eCTD Specifications
• 2/27/2025 – Updated Date Support Begins for: FDA Regional Controlled Vocabulary eCTD 4.0 Package v1.0; FDA Regional eCTD v4.0 Module 1 Implementation Guide v1.7
• 2/21/2025 - Updates to eCTD v4.0 Comprehensive Table of Contents Headings and Hierarchy; eCTD v4.0 Specification for Validation Criteria
  • Updated Date Support Begins for: ICH eCTD v4.0 Controlled Vocabulary Package v1.0; ICH Implementation Guide Package v1.6; eCTD File Format Specifications v9.2

2024

• 9/16/2024 - Date Support Begins Added

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Submission Standards for eCTD v4.0

Use/Regulatory Reference	Type	Version	Implementation Guide Reference	Date Support Begins	Date Requirement Begins	Support Ends
eCTD v4.0 Comprehensive Table of Contents Headings and Hierarchy	Documentation and Resources	2.2		2/18/2025
ICH eCTD v4.0 Implementation Guide (IG) Package (IG, Package History, and Schema Files) Previous Version ICH eCTD v4.0 Implementation Package (Implementation Guide, Controlled Vocabulary, Genericode Files, and Schema Files) Version: 1.5 Support begins: 9/16/2024	Documentation and Resources	1.6	M8 eCTD: Electronic Common Technical Document Specifications	2/18/2025
ICH eCTD v4.0 Controlled Vocabulary (CV) Package (CV and Genericode Files) Previous Version ICH eCTD v4.0 Implementation Package (Implementation Guide, Controlled Vocabulary, Genericode Files, and Schema Files) Version: 1.5 Support begins: 9/16/2024	Documentation and Resources	1.0		2/18/2025
FDA Regional eCTD v4.0 Module 1 Implementation Guide Previous Version FDA Regional eCTD v4.0 Module 1 Implementation Guide Version: 1.8 Support begins: 10/20/2025 FDA Regional eCTD v4.0 Module 1 Implementation Package (Implementation Guide, Controlled Vocabulary) Version: 1.5.1 Support begins: 9/16/2024	Documentation and Resources	1.9		TBD
FDA Regional Controlled Vocabulary (CV) eCTD v4.0 Package (CV and Genericode CV Files) Previous Version FDA Regional Controlled Vocabulary (CV) eCTD v4.0 Package (CV and Genericode CV Files) Version: 1.1 Support begins: 7/9/2026 FDA Regional Controlled Vocabulary (CV) eCTD v4.0 Package (CV and Genericode CV Files) Version: 1.0 Support begins: 3/31/2025 FDA Regional eCTD v4.0 Module 1 Implementation Package (Implementation Guide, Controlled Vocabulary) Version: 1.5.1 Support begins: 9/16/2024	Documentation and Resources	1.2		TBD
FDA Regional Forward Compatibility XML Samples	Supportive Files	1.0
FDA Regional Module 1 XML Samples	Supportive Files	3.0
eCTD v4.0 Technical Conformance Guide	Documentation and Resources	1.5	Final Guidance for Industry: Providing Regulatory Submissions in Electronic Format – eCTD Specifications	7/9/2026
Guidance for Industry: eCTD v4.0 Q&A and Change Requests	Documentation and Resources		ICH M8 technical specification, eCTD IWG Question and Answer and Specification Change Request Document
Portable Document Format Specifications	Documentation and Resources	4.1		9/21/2016	5/5/2017 (for NDA, ANDA, BLA) 5/5/2018 (IND Commercial, MF)
Specifications for eCTD v4.0 Validation Criteria	Documentation and Resources	1.6		8/28/2026
Specifications for File Format Types Using eCTD Specifications	Documentation and Resources	9.3		8/20/2025	5/5/2017 (for NDA, ANDA, BLA) 5/5/2018 (IND Commercial, MF)
Transmission Specifications	Documentation and Resources	2.0		7/9/2026	5/5/2017 (for NDA, ANDA, BLA) 5/5/2018 (IND Commercial, MF)

Validation Tools and Electronic Submission Validation Criteria in Use

Tool Name	Standard Being Validated	Tool Version in Use	Tool in Use as of Date	Validation Criteria
Lorenz eValidator	eCTD 4.0	25.2	8/25/2026	Specification for eCTD v4.0 Validation Criteria
Pinnacle 21 Enterprise	SDTM, SEND, ADaM, ASCII, Define, XML	3.2	11/4/2017	FDA Business Rules and FDA Validator Rules