Electronic Common Technical Document (eCTD)

The Electronic Common Technical Document (eCTD) is CDER/CBER’s standard format for electronic regulatory submissions. Beginning May 5, 2017 submission types NDA, ANDA, BLA and Master Files must be submitted in eCTD format. Commercial IND submissions must be submitted in eCTD format beginning May 5, 2018. Submissions that do not adhere to the requirements stated in the eCTD Guidance will not be filed or received.

As of the timeframes stated above, submissions sized 10GB and under must be submitted via the FDA Electronic Submission Gateway. Because most submissions fall within these limits, submitters are strongly advised to obtain Gateway accounts as soon as possible. You must submit electronic submissions using the version of eCTD currently supported by FDA. The version of eCTD currently supported is specified in the Data Standards Catalog.

FDA has exempted all submissions regarding noncommercial INDs from the requirements under section 745A(a). Although these submissions will be exempt, FDA also accepts their submission electronically. For additional information on the guidance, including additional exemptions, please refer to the Final Guidance for Industry: Providing Regulatory Submissions in Electronic Format – eCTD Specifications.

Important Notices

eCTD Documentation and Resources

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).

Getting Started

If you have not previously submitted in eCTD format, or have an electronic submissions gateway account, an ESG account and sample submissions are needed before your initial submission.


The FDA periodically publishes guidances on many matters, including eCTD. Those related to eCTD can be found below:




For presentations, webinars, conference dates and other related information, see below: 

Additional Resources

For fact sheets on eCTD requirements and ESG submission, see below:

For information regarding specific eCTD submissions:

Technical Assistance

If you have questions for CDER, please contact CDER ESUB at esub@fda.hhs.gov.

If you have questions for CBER, please contact CBER ESUB at esubprep@fda.hhs.gov.

Page Last Updated: 10/25/2016
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