eCTD Submission Standards for eCTD v3.2.2 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 v3.2.2 and Module 1 v3.3
• Validation Tools and Electronic Submission Validation Criteria in Use

Version History 

2025

• 02/21/2025 – Updates to eCTD Comprehensive Table of Contents Headings and Hierarchy; Updated Support Begins for Valid Values.xml v6.0; Removed Valid Values v5.0
• 02/12/2025 – Updates to File Format Specification

2024

• 03/20/2024 – Updates to File Format Specification
• 09/09/2024 – Updates version of Lorenz tool, eCTD Technical Conformance Guide, and Comprehensive Table of Contents Headings and Hierarchy; adding Valid-Values.xml v6.0

2023

• 12/01/2023 – Updates to File Format Specification

2022

• 3/15/2022 - Version 4.4    
  • Removal of M1 v1.3 and Supportive Files section (M1 Specification v1.3, eCTD CTOC v1.2.2, US Regional DTD 2.01, US Regional Stylesheet v1.1); Updates to eCTD Validation Criteria and eCTD Technical Conformance Guide
• 5/11/2022 - Version 4.5
  • Updates made to eCTD Validation Criteria
• 8/12/2022 - Version 4.6
  • Updates made to File Format Specification
• 11/4/2022 - Version 4.7
  • Updates made to the eCTD Technical Conformance Guide and Lorenz docuBridge tool version
• 12/01/2022 - eCTD Submission Standards migrated to the web

2021

• 3/15/2021 - Version 3.9
  • Updates made to eCTD Validation Criteria, form-type.xml, and File Format Specification; Removal of valid-values v2.2 and v3.0 which are no longer supported
• 5/28/2021 - Version 4.0
  • Updates made to File Format Specification and eCTD Validation Criteria
• 6/24/2021 - Version 4.1
  • Updates made to Transmission Specification and eCTD Validation Criteria
• 8/16/2021 - Version 4.2
  • Updates made to the eCTD Validation Criteria; Date Requirement Begins listed for M1 v. 2.5 and Supportive Files and M1 v. 2.5 Attribute List
• 10/1/2021 - Version 4.3
  • Updates made to Technical Conformance Guide and File Format Specification

---

Submission Standards for eCTD v3.2.2 and Module 1 v3.3 

Search:

Show 102550100All entries

Use/Regulatory Reference	Type	Version	Implementation Guide Reference	Date Support Begins	Date Requirement Begins	Date Support Ends
Addendum 2 to the eCTD Backbone Files Specification for Module 1	M1 and Supportive Files	2.3		6/15/2015	3/1/2022
Addendum to the eCTD Backbone Files Specification for Module 1	M1 and Supportive Files	2.3		6/15/2015	3/1/2022
applicant-contact-type	M1 Attribute List	1.2		6/15/2015	3/1/2022
application-type	M1 Attribute List	1.1		6/15/2015	3/1/2022
Comprehensive Table of Contents Headings and Hierarchy	M1 and Supportive Files	2.3.5		02/18/2025	3/1/2022
Current eCTD v3.2.2 Q&A document	Documentation and Resources	1.0	ICH M2 technical specification, eCTD IWG Question and Answer and Specification Change Request Document	3/01/2005
eCTD Backbone File Specification for Modules 2 through 5	Documentation and Resources	3.2.2	M2 eCTD: Electronic Common Technical Document Specifications	7/16/2008	5/5/2017 (for NDA, ANDA, BLA) 5/5/2018 (IND Commercial, MF)
eCTD Technical Conformance Guide	Documentation and Resources	1.9	Final Guidance for Industry: Providing Regulatory Submissions in Electronic Format – eCTD Specifications	09/09/2024
Example Submissions using the eCTD Backbone Files Specification for Module 1	M1 and Supportive Files	1.4		6/15/2015
form-type	M1 Attribute List	1.4		3/15/2021	3/1/2022

Showing 1 to 10 of 33 entries

• Previous
• 1
• 2
• 3
• 4
• Next

---

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	23.1	09/09/2024	Specifications for eCTD Validation Criteria
Pinnacle 21 Enterprise	SDTM, SEND, ADaM, ASCII, Define, XML	3.2	11/4/2017	FDA Business Rules and FDA Validator Rules