eCTD Submission Standards for eCTD v4.0 and Regional M1
CDER and CBER are accepting new regulatory applications in eCTD v4.0 format as of September 16, 2024. More information can be found on the eCTD page.
Future implementation phases will address forward compatibility for existing v3.2.2 applications and two-way communication.
The table below lists all the documents and supportive files applicable to eCTD submissions to CDER and CBER.
Submission Standards for eCTD v4.0
Validation Tools and Electronic Submission Validation Criteria in Use
Version History
- 2/27/2025 – Updated Date Support Begins for: FDA Regional Controlled Vocabulary eCTD 4.0 Package v1.0; FDA Regional eCTD v4.0 Module 1 Implementation Guide v1.7
- 2/21/2025 - Updates to eCTD v4.0 Comprehensive Table of Contents Headings and Hierarchy; eCTD v4.0 Specification for Validation Criteria
- Updated Date Support Begins for: ICH eCTD v4.0 Controlled Vocabulary Package v1.0; ICH Implementation Guide Package v1.6; eCTD File Format Specifications v9.2
- Updated Date Support Begins for: ICH eCTD v4.0 Controlled Vocabulary Package v1.0; ICH Implementation Guide Package v1.6; eCTD File Format Specifications v9.2
- 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 | 2.2 | 2/18/2025 | |||
| 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 | 2/18/2025 | ||
| ICH eCTD v4.0 Controlled Vocabulary (CV) Package (CV and Genericode Files) | Documentation and Resources | 1.0 | 2/18/2025 | |||
| 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 | 2/18/2025 | |||
| FDA Regional Controlled Vocabulary (CV) eCTD v4.0 Package (CV and Genericode CV Files) | Documentation and Resources | 1.0 | 2/18/2025 | |||
| 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 | 1.4 | 2/18/2025 | |||
| Specifications for File Format Types Using eCTD Specifications | Documentation and Resources | 9.2 | 2/18/2025 | 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 |