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Electronic Submissions Gateway Life Sciences

Most Frequently Asked Questions About The Electronic Submissions Gateway (ESG)

1.Why did I receive an invalid certificate error?

The following error was received when trying to import a digital certificate using the FDA ESG Web interface: "Invalid certificate file An error has occurred while importing the certificate file. Most likely you selected the wrong file type."

• Check the file extension. The file extension must be ".p7b" or ".cer". Files with these extensions represent the public key part of the certificate. Only the public key part of the certificate can be imported. Reference Appendix C, Digital Certificates in the User Guide for more information.
• Make sure the local PC has been configured to recognize and use the digital certificate. Reference the operating system instructions on the local PC for more information.

2.Why did I receive a signing encryption error?

Be sure to use the public key certificate that matches the certificate on file with FDA ESG. Verify the correct public key certificate was uploaded during the registration process by contacting the FDA ESG administrator and comparing the md5 fingerprints within the certificate.

3.When registering for another account, an error is received that says "Company name already exists". How can this error be addressed?

The error indicates that there is already a company registered with exactly the same name. Company names cannot be identical for different registered accounts. For example, "ABCDrugs" can be used for only one account registration. The name must be changed in some way for other registrations. An example would be to use "ABCDrugsAS2" for the AS2 protocol registration and "ABCDrugsWT" for the WebTrader protocol registration. Other examples would be to use "ABCDrugs" for one account and "BBBDrugs" for another or "ABCDrugs.1" and ABCDrugs.2".

4.Is it possible for a company to use both the FDA ESG web interface and the Gateway-to-Gateway exchange with the FDA ESG? For example, a company may want to send ISCR reports via the Gateway-to-Gateway exchange and other submissions via the FDA ESG web interface.

Yes. The scenario described above is acceptable. Registration can be for any number of AS2 or FDA ESG WebTrader accounts. For example, there can be three AS2 accounts registered in addition to eight WebTrader accounts.

5. Why did I receive a private key error?

This error occurs when there is a mismatch between the public and private key for a certificate. Check to ensure the correct private key for the public certificate sent to the FDA ESG is in place.Obtain the correct private key and resend the document.

Source:https://www.fda.gov/ForIndustry/ElectronicSubmissionsGateway/ucm114807.htm