FDA Electronic Submissions Gateway (ESG)

GNSI developed the U.S. Food and Drug Administration’s (FDA) Electronic Submissions Gateway (ESG) as an Agency-wide solution for accepting electronic regulatory submissions. The FDA ESG is the central transmission point for sending regulatory information electronically to the FDA. Since its inception in May 2006, the ESG has processed over 800,000 electronic submissions from over 1,200 industry trading partners to the FDA Center for Biologics Evaluation and Research, Center for Drug Evaluation and Research, Center for Devices and Radiological Health, Center for Veterinary Medicine, and Office of the Commissioner. The FDA ESG also supports the receipt of Adverse Event Reporting System (AERS) reports and AERS attachments.

The FDA ESG is the entry point through which electronic regulatory submissions travel from the Internet to their final destination within the FDA. The gateway does not open or review submissions; it automatically routes them to the proper FDA Center or Office. The FDA ESG provides for the secure submission of regulatory information using SSH, X.509 v3 certificates, and open standards developed for B2B transactions. These standards include acknowledgement of submission receipt such that end users are provided with documentation of the full transaction lifecycle. Use of the FDA ESG for electronic submissions decreases the time and cost associated with these submissions for both large and small companies. In fact, with electronic submission same day delivery is possible. We estimate that a large pharmaceutical company that is currently sending 1,500 submissions manually will save over $80,000 by submitting them using the ESG. Similarly, a small pharmaceutical company that sends 100 electronic submissions using the ESG will save over $5,000.

In June 2009 the FDA required drug establishment registrations and listings to be submitted electronically. This has resulted in the registration of hundreds of new trading partners and significantly more traffic through the FDA ESG. The list of electronic regulatory submissions that can be received by the FDA ESG will continue to be expanded as the FDA promulgates additional electronic submission guidance documents and extends this capability to new operational units within FDA.

Visit the FDA’s Electronic Submissions Gateway.