FDA Modernizes the Electronic Submission Gateway (ESG) with ESG NextGen

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FDA Modernizes the Electronic Submission Gateway (ESG) with ESG NextGen

The FDA is launching ESG NextGen, a modern, cloud-based system designed to improve the submission process. Key features include a unified submission portal, real-time tracking, enhanced cybersecurity, and API integration. This modernization expands bandwidth and storage capacity, allowing for a more seamless and efficient experience.

FDA Modernizes the Electronic Submission Gateway (ESG) with ESG NextGen
FDA Modernizes the Electronic Submission Gateway (ESG) with ESG NextGen

ESG NextGen aims to improve the user experience and provide advanced capabilities to manage larger-sized submissions, particularly in response to public health emergencies. Additionally, it offers the FDA and industry partners a robust system that can swiftly adapt to changing regulatory needs and evolving public health requirements.

Key Features of Electronic Submission Gateway NextGen:
  • Unified Submission Portal: Easier, faster document submissions replacing the WebTrader application.
  • Real-Time Tracking: Track your submissions anytime for improved transparency.
  • Enhanced Cybersecurity: Multi-factor authentication for secure data handling.
  • API Integration: Direct system connections for automated workflows and real-time updates.
In preparation for the April 14, 2025, launch of the ESG NextGen system, the FDA is opening the Test Submissions phase of the launch from March 31, 2025 through April 11, 2025. During this time, users will have the opportunity to:
  1. Perform test submissions.
  2. Validate/update data that has been migrated from legacy ESG to Electronic Submission Gateway (ESG) NextGen.
  3. Review training material and get acclimated with the new system in advance of go-live.
Key Transition Dates and Activities: 
  • March 28 – 30, 2025: Legacy ESG production data will be migrated to ESG NextGen.
  • March 31 – April 11: An open period for users to conduct submissions testing and validate/update data migrated from legacy ESG.New registrations must be completed in both legacy ESG and ESG NextGen during this period.
  • April 12, at 12:00 AM – April 14, at 9:00 AM (EDT): Legacy ESG, including WebTrader and AS2 accounts, will be disabled and not available for use. Hold ALL submissions during this time period.
  • April 14, 2025, at 9:00 AM (EDT): ESG NextGen is officially live, and all Test and Production submissions must be submitted in ESG NextGen. Navigate to Electronic Submissions Gateway | FDA to access ESG NextGen.
To prepare, please refer to the links below for helpful guides and training resources.

Navigate to Electronic Submissions Gateway | FDA and click on the Industry USP Log In button to access ESG NextGen USP.

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