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  6. eCTD Submission Standards for eCTD v3.2.2 and Regional M1
  1. Electronic Regulatory Submission and Review

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 

  • 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

  • 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

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

  • 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

  • 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 

Use/Regulatory ReferenceTypeVersionImplementation Guide ReferenceDate Support BeginsDate Requirement BeginsDate Support Ends
eCTD Technical Conformance GuideDocumentation and Resources1.9Final Guidance for Industry: Providing Regulatory Submissions in Electronic Format – eCTD Specifications09/09/2024  
eCTD Backbone File Specification for Modules 2 through 5Documentation and Resources3.2.2M2 eCTD: Electronic Common Technical Document Specifications7/16/20085/5/2017 (for NDA, ANDA, BLA) 5/5/2018 (IND Commercial, MF) 
The eCTD Backbone File Specification for Study Tagging FilesDocumentation and Resources2.6.1 6/03/20085/5/2017 (for NDA, ANDA, BLA) 5/5/2018 (IND Commercial, MF) 
Specifications for eCTD Validation Criteria (PDF)Documentation and Resources4.4 5/11/20225/5/2017 (for NDA, ANDA, BLA) 5/5/2018 (IND Commercial, MF) 
Specifications for eCTD Validation Criteria (XLS)Documentation and Resources4.4 5/11/20225/5/2017 (for NDA, ANDA, BLA) 5/5/2018 (IND Commercial, MF) 
Portable Document Format SpecificationsDocumentation and Resources4.1 9/21/20165/5/2017 (for NDA, ANDA, BLA) 5/5/2018 (IND Commercial, MF) 
Transmission SpecificationsDocumentation and Resources1.9 6/14/20215/5/2017 (for NDA, ANDA, BLA) 5/5/2018 (IND Commercial, MF) 
Specifications for File Format Types Using eCTD SpecificationsDocumentation and Resources9.2 2/18/20255/5/2017 (for NDA, ANDA, BLA) 5/5/2018 (IND Commercial, MF) 
Guidance for Industry: eCTD Q&A and Change RequestsDocumentation and Resources1.0ICH M2 technical specification, eCTD IWG Question and Answer and Specification Change Request Document3/01/2005  
Current eCTD v3.2.2 Q&A documentDocumentation and Resources1.0ICH M2 technical specification, eCTD IWG Question and Answer and Specification Change Request Document3/01/2005  
ICH website containing links to Q&A and Change Request FormDocumentation and Resources1.0ICH M2 technical specification, eCTD IWG Question and Answer and Specification Change Request Document3/01/2005  
ICH eCTD DTDSupportive Files3.2 11/01/20035/5/2017 (for NDA, ANDA, BLA) 5/5/2018 (IND Commercial, MF) 
ICH eCTD StylesheetSupportive Files2 11/01/20045/5/2017 (for NDA, ANDA, BLA) 5/5/2018 (IND Commercial, MF) 
ICH-STF DTDSupportive Files2.2 8/01/20035/5/2017 (for NDA, ANDA, BLA) 5/5/2018 (IND Commercial, MF) 
ICH STF StylesheetSupportive Files2.3 6/01/20175/5/2017 (for NDA, ANDA, BLA) 5/5/2018 (IND Commercial, MF) 
Valid Values.xmlSupportive Files6.0 02/18/2025  
The eCTD Backbone Files Specification for Module 1M1 and Supportive Files2.3.4 11/09/20203/1/2022 
Comprehensive Table of Contents Headings and HierarchyM1 and Supportive Files2.3.5 02/18/20253/1/2022 
Addendum to the eCTD Backbone Files Specification for Module 1M1 and Supportive Files2.3 6/15/20153/1/2022 
Addendum 2 to the eCTD Backbone Files Specification for Module 1M1 and Supportive Files2.3 6/15/20153/1/2022 
Example Submissions using the eCTD Backbone Files Specification for Module 1M1 and Supportive Files1.4 6/15/2015  
US Regional DTDM1 and Supportive Files3.3 6/15/20153/1/2022 
US Regional StylesheetM1 and Supportive Files2.2 6/15/2015  
applicant-contact-typeM1 Attribute List1.2 6/15/20153/1/2022 
telephone-number-typeM1 Attribute List1.1 6/15/20153/1/2022 
application-typeM1 Attribute List1.1 6/15/20153/1/2022 
submission-typeM1 Attribute List1.3 7/27/20203/1/2022 
submission-sub-typeM1 Attribute List1.1 6/15/20153/1/2022 
supplement-effective-date-type M1 Attribute List1.1 6/15/20153/1/2022 
form-typeM1 Attribute List1.4 3/15/20213/1/2022 
promotional-material-audience-typeM1 Attribute List1.1 6/15/20153/1/2022 
promotional-material-doc-typeM1 Attribute List1.2 6/15/20153/1/2022 
promotional-material-typeM1 Attribute List1.3 8/15/20193/1/2022 

Validation Tools and Electronic Submission Validation Criteria in Use

Tool NameStandard Being ValidatedTool Version in UseTool in Use as of DateValidation Criteria
Lorenz eValidatoreCTD23.109/09/2024Specifications for eCTD Validation Criteria
Pinnacle 21 EnterpriseSDTM, SEND, ADaM, ASCII, Define, XML3.211/4/2017FDA Business Rules and FDA Validator Rules
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