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FDA 更新 eCTD v3.2.2 与区域 M1 提交标准：eCTD 验证标准规范更新至 4.7 版
eCTD Submission Standards for eCTD v3.2.2 and Regional M1
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FDA 更新 eCTD v3.2.2 与 Module 1 v3.3 提交标准，eCTD 验证标准规范更新至 4.7 版，日期为 10/16/2026。传输规范更新至 2.0 版（7/9/2026），文件格式类型规范为 9.3 版（8/20/2025）。上述标准适用于向 CDER 和 CBER 提交的 eCTD。
正文 · 原文
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
2026
- 10/16/2026 – Updates to Specification for eCTD Validation Criteria
- 08/28/2026 – Updates to Specification for eCTD Validation Criteria
- 07/09/2026 – Update to Transmission Specifications
2025
- 10/20/2025 – Updates to Specification for eCTD Validation Criteria, Removed XLS version of Validation Criteria
- 8/20/2025 – Updates to Specification for File Format Types Using eCTD Specifications
- 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
| Use/Regulatory Reference | Type | Version | Implementation Guide Reference | Date Support Begins | Date Requirement Begins | Date Support Ends |
|---|---|---|---|---|---|---|
| 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 | 4.7 | 10/16/2026 | 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 | 2.0 | 7/9/2026 | 5/5/2017 (for NDA, ANDA, BLA) 5/5/2018 (IND Commercial, MF) | ||
| Specifications for File Format Types Using eCTD Specifications | Documentation and Resources | 9.3 | 8/20/2025 | 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 | 6.0 | 02/18/2025 | |||
| The eCTD Backbone Files Specification for Module 1 | M1 and Supportive Files | 2.6 | 03/31/2025 | 3/1/2022 | ||
| Comprehensive Table of Contents Headings and Hierarchy | M1 and Supportive Files | 2.3.5 | 02/18/2025 | 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 |
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 | 25.2 | 08/25/2026 | 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 |
来源：FDA 官方药品与生物制品信息 · fda.gov