Jun 4, 2026
IMPORTANT NOTICE: If you are using a legacy FDA ESG Portal, the content of this page applies. However, if you have transitioned to the ESG NextGen Portal, please contact the FDA ESG Help Desk to confirm certificate requirements for your account. Then, please follow the instructions from ESG NextGen AS2 Account Set-Up Steps to continue.
According to the latest update, submissions via Unified Submission Portal (USP) or API no longer require certificates, but if you are using an AS2 Gateway connection, you must still use digital certificates. To learn more about ESG NextGen, please refer to this FDA documentation.
This error may occur if the user incorrectly enters the pass phrase to their certificate. Be sure to remember the pass phrase to your certificate as this information is only known by the certificate owner and cannot be retrieved elsewhere.
This error may also occur when a user attempts to sign an FDA ESG submission within their WebTrader Account by using a file that does not contain a private key. Make sure the file you are selecting has the extension .pfx (Personal Information Exchange).
When sending a submission to the FDA ESG, it is signed using the private key of your digital certificate. The FDA ESG must have the corresponding public key (a ".cer" or ".p7b" file) from the same certificate stored in your WebTrader account in order to verify the signature. To fix this error, please follow the instructions for updating your public key.
You may see this error even when your certificate is still valid. The .pfx used to sign submissions contains more than just your certificate. It also contains a GlobalSign Intermediate certificate that is periodically updated. If you receive this error and your certificate is still valid, re-export your private key and use the newly exported file to process submissions. Re-exporting will pull the updated Intermediate certificate into the .pfx.
Check your certificate installation for SSL issues and vulnerabilities.