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Electronic Common Technical Document (eCTD)
FDA would like to work closely with people who plan to provide a submission using the eCTD specifications and offer the following steps to help smooth the process.
NOTICE: Important instructions regarding electronic submissions, effective January 1, 2008.
NOTICE: Important information on requesting a pre-assigned application for your future eCTD submission
1. Review the eCTD specifications
The following are the specifications for creating the eCTD Backbone Files and Study Tagging Files (eCTD Specifications). The specifications are listed below.
Specifications
2. Contact the FDA before creating a submission using the eCTD specifications
Initiating contact with the FDA helps to begin a productive dialog, ensuring that both technical sides are working from the same set of information. When ready to begin creating an eCTD, contact the FDA at esub@fda.hhs.gov to inform them of your plans. When sending an email please include the
following:
- Contact Person Name - This will be the main contact during the sample eCTD submission phase.
- Contact Person's Company Name
- Contact Person's Mailing Address
- Contact Person's Phone Number
- Contact Person's Email Address
- Date When You Plan To Submit An Application
3. The FDA provides a number for the sample eCTD submission
Once the industry participant has submitted their contact information, a technical representative from the FDA will contact them and assign a number for the sample, as well as arrange a time to test the sample.
4. Submit a sample submission using the eCTD specification for testing
This is a sample submission and is not considered a official eCTD submission.
5. The FDA tests sample submission
The FDA will process the sample submission to ensure that it conforms to
the FDA eCTD Guidance, Specifications and ICH eCTD guidelines. These tests
include but are not limited to DTD validation, verification of file checksums,
verification of the presence of the modified file, and identification of
missing files.
This sample eCTD submission will NOT be reviewed by an FDA reviewer
during this initial test. The FDA will provide the participant with a report
highlighting the errors found during the initial processing of the sample eCTD
submission.
6. Resolve any technical issues with the submission
The industry participant should correct all errors provided by the FDA. The revised sample eCTD submission should use the same submission sequence number.
7. Resubmit sample submission
The industry participant should resubmit the corrected sample submission.
After the successful completion of these steps, the submissions should be
technically ready to be officially submitted to the Agency. This testing phase
does not involve any review of the content of the submission and is intended
to only resolve technical issues. For additional information, contact the FDA
at esub@cder.fda.gov.
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Date updated: November 12, 2008 |
