The United Food and Drug Administration (US FDA) has made an announcement to all WebTrader account holders using the Electronic Submission Gateway (ESG) of their timelines for implementation of the ESG “Next Generation”.
WebTrader is currently mandated to be used by companies and consultants submitting on behalf of companies, to transmit Canadian drug applications electronically to Health Canada via the US FDA’s ESG system.
Users of the ESG have been apprised of the progress on the implementation of the ESG Next Generation here since 2023.
The current ESG system will be disabled starting April 12, 2025, at 12:00 AM ET.
ESG NextGen will go live on April 14, 2025.
No submissions can be made between April 12, 2025, at 12:00 AM ET and April 14, 2025, at 9:00 AM ET during the transition to ESG NextGen.
A notification will be sent once ESG NextGen is live and available for submissions on April 14, 2025. Additional information will be communicated via email to current ESG users by mid-March.
Some new features of the system include:
- A user-friendly online portal (Unified Submission Portal) that makes submitting documents faster and easier, replacing the WebTrader application).
- Real-time tracking and reports so you can see the status of your submissions at any time.
- Improved transparency with real-time tracking and reporting.
- Enhanced cybersecurity with multi-factor authentication and improved access control. with multi-factor authentication and better access controls to keep your information safe.
- The new Application Programming Interface (API) allows systems to connect directly, automating workflows and providing real-time updates.
More details and FAQs on the ESG NextGeneration may also be found here to assist you with the transition and details what you need to do and what you do not need to do ahead of the transition.
Granular Key Transition Dates
o March 28 – 30, 2025: Legacy ESG production data will be migrated to ESG NextGen.
o March 31 – April 9: An open period for users to conduct submissions testing and validate/update data migrated from legacy ESG.
o April 12, at 12:00 AM – April 14, at 9:00 AM (EDT): Legacy ESG, including WebTrader and AS2 accounts, will be disabled. Hold ALL submissions during this time.
o April 14, 2025, at 9:00 AM (EDT): ESG NextGen is officially live, and Test and Production submissions will be enabled. We’ll send an email notification as a reminder.
