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In this section: Electronic Regulatory Submission and Review

eCTD Submission Standards for eCTD v4.0 and Regional M1

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

9/16/2024 - Date Support Begins Added

Submission Standards for eCTD v4.0

Use/Regulatory Reference	Type	Version	Implementation Guide Reference	Date Support Begins	Date Requirement Begins	Date Support Ends
eCTD v4.0 Comprehensive Table of Contents Headings and Hierarchy	Documentation and Resources	2.1		9/16/2024
ICH eCTD v4.0 Implementation Package (Implementation Guide, Controlled Vocabulary, Genericode Files, and Schema Files)	Documentation and Resources	1.5	M8 eCTD: Electronic Common Technical Document Specifications	9/16/2024
ICH eCTD v4.0 Implementation Guide (IG) Package (IG, Package History, and Schema Files)	Documentation and Resources	1.6	M8 eCTD: Electronic Common Technical Document Specifications	TBD
ICH eCTD v4.0 Controlled Vocabulary (CV) Package (CV and Genericode Files)	Documentation and Resources	1.0		TBD
FDA Regional eCTD v4.0 Module 1 Implementation Package (Implementation Guide, Controlled Vocabulary)	Documentation and Resources	1.5.1		9/16/2024
FDA Regional eCTD v4.0 Module 1 Implementation Guide	Documentation and Resources	1.7		TBD
FDA Regional Controlled Vocabulary (CV) eCTD v4.0 Package (CV and Genericode CV Files)	Documentation and Resources	1.0		TBD
FDA Regional Module 1 XML Samples	Supportive Files	3.0
eCTD v4.0 Technical Conformance Guide	Documentation and Resources	1.3	Final Guidance for Industry: Providing Regulatory Submissions in Electronic Format – eCTD Specifications	9/16/2024
Guidance for Industry: eCTD v4.0 Q&A and Change Requests	Documentation and Resources	1.8	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	1.3.1		9/16/2024
Specifications for File Format Types Using eCTD Specifications	Documentation and Resources	9.1		3/20/2023	5/5/2017 (for NDA, ANDA, BLA) 5/5/2018 (IND Commercial, MF)
Transmission Specifications	Documentation and Resources	1.9		6/14/2021	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	23.1	9/16/2024	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

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