FDA ELECTRONIC SUBMISSIONS GATEWAY (ESG)

Quick Links

• User Guide ( PDF)– The User Guide provides industry participants with information and guidance on how to use the FDA ESG.
• Set up an Account – Step-by-step description of how to register for and set up an FDA ESG account.
• FAQ's – Frequently Asked Questions
• Impact of Moving to Electronic Submissions and the ESG – Sending electronic submissions to the FDA using the ESG can have a positive impact, both in terms of return on investment and on your existing regulatory practices.
• System Requirements– Minimum system hardware and software requirements that must be met by FDA ESG Web Interface users and AS2 Gateway-to-Gateway users.
• Submission Types by Center – List of submission types accepted by each FDA Center through the FDA ESG.
• Center-Specific Submission Preparation Guidelines – Links to guidelines on preparing regulatory compliant electronic submissions.
• Digital/Electronic Signatures – Important information on the use of digital/electronic signatures on FDA forms.
• Digital Certificates – Information on how to obtain a digital certificate for private and secure submission of electronic documents.
• Sample Letters of Non-Repudiation Agreement – How to submit the Letter of Non-Repudiation Agreement required by 21 Code of Federal Regulations (CFR) Part 11.100.
  • Note: FDA requires you to submit a Letter of Non-Repudiation Agreement.
• Submission Statistics – Statistics on number of submissions received by the FDA ESG.
• Tutorials – Tutorials on how to register for an account and on how to set up and use the FDA ESG Web Interface.

Updates

Help Desk

Preparation/Registration/Policy Questions

Email: esgprep@fda.hhs.gov

For Technical Issues with Submissions

Email: esgreg@gnsi.com

If you have not received the Center (second) acknowledgement within 4 hours after the end of the transmission, contact esgreg@gnsi.com for assistance. Please provide the message ID for the submission, the Company name on the account, and the date and time the submission was sent.

Background and Project Status

The Food and Drug Administration (FDA) Electronic Submissions Gateway (ESG) is an Agency-wide solution for accepting electronic regulatory submissions. The FDA ESG enables the secure submission of regulatory information for review.

The electronic submission process encompasses the receipt, acknowledgment of receipt (to the sender), routing, and notification (to a receiving Center or Office) of the delivery of an electronic submission.

The FDA ESG is the central transmission point for sending information electronically to the FDA. Within that context, the FDA ESG is a conduit along which submissions travel to reach their final destination. It does not open or review submissions; it automatically routes them to the proper FDA Center or Office.

The FDA ESG supports the receipt of guidance compliant electronic regulatory submissions of up to 100GB in size to CBER, CDER, CDRH, and CVM. The FDA ESG also supports the receipt of AERS reports and AERS attachments. (See Submission Types by Center)

The FDA ESG is accepting registration requests for new test accounts as described under "Set up an Account". Please read this section and the ESG User Guide (PDF) carefully before submitting your registration request. Companies planning to transmit regulatory submissions via the WebTrader option will be asked to send a .pdf or eCTD based test submission that is 7.5 GB in size. Based on pilot testing with Industry volunteers, the FDA recommends that submissions greater than 15 GB and less than 25 GB in size be sent overnight starting at 5PM EST to ensure receipt by the targeted FDA Center during the next business day.

The FDA continues to expand ESG capabilities. These plans include receipt of:

• Electronic submissions for the Center for Food Safety and Nutrition;
• Electronic submissions for the Office of Orphan Product Designations; and
• Vaccine Adverse Event Reports (VAERS).

The list of electronic regulatory submissions that can be received by the FDA ESG will be expanded as the FDA promulgates additional electronic submission guidance documents and extends this capability to new operational units within the FDA.

Tutorials

• Uninstalling Java Runtime Edition

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• Installing Java Runtime Edition

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• Registering for a Web Based Test Account

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• Sending a Test Submission

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• Registering for an AS2 Test Account

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