eCTD v4.0 Comprehensive Table of Contents Headings and Hierarchy Documentation and Resources 2.1   9/16/2024     ICH eCTD v4.0 Implementation Package (IG, CV, 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     eCTD v4.0 Module 1 Implementation Package (Implementation Guide, CV) Documentation and Resources 1.5.1   9/16/2024     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 2.0         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)  

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