eCTD Submission Standards

eCTD Technical Conformance Guide Documentation and Resources 1.9 Final Guidance for Industry: Providing Regulatory Submissions in Electronic Format – eCTD Specifications 09/09/2024     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)   The eCTD Backbone File Specification for Study Tagging Files Documentation and Resources 2.6.1   6/03/2008 5/5/2017 (for NDA, ANDA, BLA) 5/5/2018 (IND Commercial, MF)   Specifications for eCTD Validation Criteria (PDF) Documentation and Resources 4.4   5/11/2022 5/5/2017 (for NDA, ANDA, BLA) 5/5/2018 (IND Commercial, MF)   Specifications for eCTD Validation Criteria (XLS) Documentation and Resources 4.4   5/11/2022 5/5/2017 (for NDA, ANDA, BLA) 5/5/2018 (IND Commercial, MF)   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)   Transmission Specifications Documentation and Resources 1.9   6/14/2021 5/5/2017 (for NDA, ANDA, BLA) 5/5/2018 (IND Commercial, MF)   Specifications for File Format Types Using eCTD Specifications Documentation and Resources 9.1   3/20/2024 5/5/2017 (for NDA, ANDA, BLA) 5/5/2018 (IND Commercial, MF)   Guidance for Industry: eCTD Q&A and Change Requests Documentation and Resources 1.0 ICH M2 technical specification, eCTD IWG Question and Answer and Specification Change Request Document 3/01/2005     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     ICH website containing links to Q&A and Change Request Form Documentation and Resources 1.0 ICH M2 technical specification, eCTD IWG Question and Answer and Specification Change Request Document 3/01/2005     ICH eCTD DTD Supportive Files 3.2   11/01/2003 5/5/2017 (for NDA, ANDA, BLA) 5/5/2018 (IND Commercial, MF)   ICH eCTD Stylesheet Supportive Files 2   11/01/2004 5/5/2017 (for NDA, ANDA, BLA) 5/5/2018 (IND Commercial, MF)   ICH-STF DTD Supportive Files 2.2   8/01/2003 5/5/2017 (for NDA, ANDA, BLA) 5/5/2018 (IND Commercial, MF)   ICH STF Stylesheet Supportive Files 2.3   6/01/2017 5/5/2017 (for NDA, ANDA, BLA) 5/5/2018 (IND Commercial, MF)   Valid Values xml Supportive Files 5.0   11/10/2016 5/5/2017 (for NDA, ANDA, BLA) 5/5/2018 (IND Commercial, MF)   Valid Values.xml Supportive Files 6.0   TBD     The eCTD Backbone Files Specification for Module 1 M1 and Supportive Files 2.3.4   11/09/2020 3/1/2022   Comprehensive Table of Contents Headings and Hierarchy M1 and Supportive Files 2.3.4   09/09/2024 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   Addendum 2 to the eCTD Backbone Files Specification for Module 1 M1 and Supportive Files 2.3   6/15/2015 3/1/2022   Example Submissions using the eCTD Backbone Files Specification for Module 1 M1 and Supportive Files 1.4   6/15/2015     US Regional DTD M1 and Supportive Files 3.3   6/15/2015 3/1/2022   US Regional Stylesheet M1 and Supportive Files 2.2   6/15/2015     applicant-contact-type M1 Attribute List 1.2   6/15/2015 3/1/2022   telephone-number-type M1 Attribute List 1.1   6/15/2015 3/1/2022   application-type M1 Attribute List 1.1   6/15/2015 3/1/2022   submission-type M1 Attribute List 1.3   7/27/2020 3/1/2022   submission-sub-type M1 Attribute List 1.1   6/15/2015 3/1/2022   supplement-effective-date-type  M1 Attribute List 1.1   6/15/2015 3/1/2022   form-type M1 Attribute List 1.4   3/15/2021 3/1/2022   promotional-material-audience-type M1 Attribute List 1.1   6/15/2015 3/1/2022   promotional-material-doc-type M1 Attribute List 1.2   6/15/2015 3/1/2022   promotional-material-type M1 Attribute List 1.3   8/15/2019 3/1/2022  

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