- eCTD Guidance (PDF -11 KB)
- eCTD Submission Standards (PDF - 91KB)
- FDA Data Standards Catalog
- eCTD Technical Conformance Guide (PDF - 303KB)
- Drug Master Files (DMFs)
- Technical Rejection Criteria for Study Data (PDF - 921 KB) NEW
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).
After the dates listed below, eCTD requirements for submissions to CDER and CBER will go into effect and submissions that do not use eCTD will not be filed or received.
- May 5, 2017: New Drug Applications (NDAs), Abbreviated NDAs (ANDAs), Biologics License Applications (BLAs), and Master Files (MFs) must be submitted using eCTD format.
- May 5, 2018: Commercial Investigational New Drug Applications (INDs) must be submitted using eCTD format.
- Please refer to the eCTD Guidance for the complete details to meet the eCTD requirement.
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 promotional materials for human prescription drug
- 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, M1 versions 1.3 and 2.3 documents related to eCTD, please refer to eCTD Submission Standards (XLS - 57KB) or eCTD Submission Standards (PDF - 91KB).
Important Notice 5/18/2016
Third Acknowledgement for Successful eCTD Submissions
Beginning May 31, 2016, CDER will begin issuing an acknowledgement to FDA Electronic Submissions Gateway (ESG) users when their NDA, ANDA, BLA, IND, or DMF submission has successfully completed validation and processing and is available to the assigned review division. This acknowledgement is in addition to the ESG Message Delivery Notification acknowledgement (first acknowledgement) and the Official Center acknowledgement (second acknowledgement) and is referred to as the “third acknowledgement.”
For additional notices, please see eCTD Important Notices.
If you have questions for CDER, please contact the CDER Electronic Submission (ESUB) Support Team at email@example.com.
If you have questions for CBER, please contact the CBER ESUB Support Team at firstname.lastname@example.org.