- NDA to BLA eCTD Transition Instruction to Industry (PDF - 90 KB)
- eCTD Guidance (Final, Rev 7) (PDF -11 KB)
- eCTD Submission Standards for eCTD v3.2.2 and Regional M1 NEW
- FDA Data Standards Catalog
- eCTD Technical Conformance Guide (PDF - 303 KB)
- Drug Master Files (DMFs)
- eCTD 4.0
- FDA FR Notice on high severity eCTD validations 1306 &1323
- FDA FR Notice on high severity eCTD validations 1551 & 1553
- FDA announces effective date for study data information
- FDA eCTD v4.0 Validation and CTOC Posted
- FDA announces end of support for US Regional DTD v2.01 on March 1, 2022
- Promotional Labeling and Advertising Materials Guidance
- Past Notices
The eCTD is the standard format for submitting applications, amendments, supplements, and reports to FDA’s Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER). Please refer to the eCTD Guidance for the complete details to meet the eCTD requirement.
Per the FDA Data Standards Catalog, the electronic submission of standardized SEND datasets to CBER is required for NDA, BLA, ANDA, and Commercial IND. FDA plans to apply eCTD validation 1734, 1735, 1736, and 1737 when CBER submissions contain content under module 4 beginning March 16, 2023. Please see the Federal Register :: Electronic Submissions; Data Standards; Support for Standard for the Exchange of Nonclinical Data, the Study Data Technical Conformance Guide, and the eCTD Validation Criteria (error code 1734, 1735, 1736, 1737) for details.
Electronic submission requirements will apply to the following types of submissions to CDER/CBER:
- Commercial IND applications (for products that are intended to be distributed commercially)
- All subsequent submissions to these types of applications, including amendments, supplements, and reports, even if the original submission was filed before the requirements went into effect
- Master files, such as DMFs, which are considered to be submissions to an IND, an NDA, an ANDA, or a BLA
Electronic submission standards will be optional but encouraged for the following categories:
- Noncommercial INDs, such as investigator-sponsored INDs and expanded-access INDs
- Submissions for blood and blood components, including source plasma
- Submissions for Type III Master Files
- Electronic submissions must use the version of eCTD currently supported by FDA, which is specified in the FDA Data Standards Catalog on the Study Data Standards Resources page. Updates to the standard will be announced on the FDA website and published in the Federal Register. The notices will include the date on which the new versions will go into effect.
- For a listing of Specifications, Supportive Files, and versions related to eCTD, please refer to eCTD Submission Standards (XLS - 57KB) or eCTD Submission Standards (PDF - 91KB).