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 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 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 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.