The Food and Drug Administration (FDA) has announced that the modernised Electronic Submissions Gateway (ESG NextGen) will officially go live on April 14th, 2025, at 9:00 AM ET.

This significant upgrade aims to enhance the electronic submission process with improved security, functionality, and tracking features.

Key Dates to Note:

• April 12th–14th, 2025: The FDA will not accept any submissions during this period as the legacy ESG system is decommissioned.
• April 14th, 2025 (9:00 AM ET): ESG NextGen becomes operational and will resume accepting both test and production submissions.

Companies are advised to ensure full preparedness for this transition to avoid any disruption in regulatory workflows.

PharSafer Is Ready:

Demonstrating our commitment to proactive compliance and client support, PharSafer has.

• Conducted thorough testing with the ESG NextGen system.
• Received successful acknowledgements from the FDA for submitted test packages.
• Ensured our systems and teams are fully prepared for the April 14th go-live.

What’s New in ESG NextGen:

• A streamlined Unified Submission Portal replaces WebTrader.
• Real-time tracking and reporting for enhanced submission visibility.
• Enhanced cybersecurity with multi-factor authentication.
• New API functionality to support automation and integration.
• Continued support for AS2 submissions to ensure a smooth transition.

Recommended Actions for MAHs and Regulatory Teams:

• Finalise readiness for ESG NextGen by aligning internal systems and processes.
• Account for the FDA blackout window (April 12th–14th) in submission planning.
• Contact esgngsupport@fda.hhs.gov if communication from the FDA has not been received.

PharSafer is committed to supporting our clients during this transition.

If you have any questions or require further guidance, please contact us directly: enquiries@pharsafer.com 📧