FDA continues to implement regulations requiring that submissions be made in electronic format. The regulations specify that submissions to the Agency be made electronically in a form that FDA can process, review, and archive. The regulations also state that FDA will periodically issue guidance on how to provide electronic submission of information previously submitted in paper format.

New Technology for Processing Submissions to FDA

The new final and tentative regulations require that submissions be made in a form that FDA can process, review, and archive. Since 1999, FDA has been receiving the electronic submissions in Portable Document Format (PDF), and this format has allowed the Agency to process, review and archive the submitted data. Recently, however, recommendations from the Institute of Medicine and the National Committee on Vital and Health Statistics have created a new role for electronic submission of information. Electronically formatted submissions will be used to support health information management technologies. To support the new programs, the Agency is changing the way it processes, reviews, and archives the content of labeling. The Agency is adopting a new technology for exchanging information between computer systems in extensible markup language (XML).

XML allows the efficient and timely exchange of information between computer systems. The information in XML files submitted to the Agency can be used to support health information technology initiatives for improving patient care. XML can also be used to exchange information needed for various submissions, such as drug listing, thus eliminating redundant data collection and improving efficiency. The Agency is changing to XML format so that the information can be used in a variety of ways — searched, moved between systems, combined with other data sources — to support electronic health initiatives. Although XML is the new standard for data transmission to the Agency, PDF’s will still be used in specific cases and in conjunction with XML’s as needed so it is unlikely that PDF’s will become 100% obsolete.

The Electronic Submissions Gateway (ESG)

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. The FDA ESG also supports the receipt of CDRH, CVM, CTP, OC, VAERS and AERS reports and attachments.

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