Insights

The Food and Drug Administration (FDA) has announced the go-live of the Electronic Submission Gateway Next Generation (ESG NextGen) starting from April 14, 2025 to perform electronic submissions. The Electronic Submission Gateway (ESG) is now retired and is no longer available for submissions; information from WebTrader accounts will be migrated over to ESG NextGen.

ESG NextGen is the FDA’s modernized platform for securely receiving and processing electronic regulatory submissions with improved architecture that supports greatly expanding submission bandwidth and storage.

ESG NextGen functions as a unified solution, serving as a single-entry point for the secure submission, receipt, acknowledgment, routing, and notification of all regulatory submissions to the FDA.

• Unified Submission Portal (USP): The ESG NextGen USP is a user-friendly web-based platform which replaces the legacy WebTrader user interface. The USP provides the ability to submit regulatory information to the FDA and track the status through Center receipt.
• API Integration: ESG NextGen’s suite of APIs enables programmatic submissions, allowing organizations to integrate submission processes directly into their internal systems. This option supports the automation of submission workflows and real-time status tracking through Center receipt of the submission.
• Applicability Statement 2 (AS2): A system-to-system connection for an automated data exchange between the FDA and its partners.

The FDA has released user guides available for the USP, AS2, and API, including steps for CROs, U.S. Agents, and Consultants to create an ESG NextGen Account and information pertaining to the Non-Repudiation Letter, as well as information for agents and Authorization Letters.

Regulatory Pharma Net provides full regulatory assistance during the whole product lifecycle and is ready to support companies on all regulatory needs and to guide them through any new FDA requirement/procedure including the ESG NextGen portal.