About the FDA ESG

FAQ - FDA ESG Certificates

Due to FDA regulation changes, Digital IDs (Digital Certificates) are required for submitting electronic documentation to the FDA. GlobalSign is an approved provider of Digital IDs for the FDA Electronic Submissions Gateway (ESG).

Please find below frequently asked questions when using a GlobalSign Digital ID to submit documents to the FDA ESG.

 

1. Who needs an FDA ESG Digital ID?

2. The FDA tells me I need an X.509V3 Digital Certificate. What certificate should I choose?

3. The FDA guidelines references an option to create a self signed certificate using Adobe Acrobat. How does that work?

4. I am on the FDA gateway site and section 4.1 Apply for a Test Account and Step 8: Locate the certificate file is asking me to Locate an X,509 Version 3 certificate file, where I must upload the certificate file to their website. "Enter the name of the certificate file to import. The file must have an extension of .cer, .p7b, or .p7c." What is the file name and where is it located on my computer, it did not say so during the registration process?

5. After initial registration, the FDA requires me to put my certificate into a .PFX or PKCS12 format to actually submit electronically signed documents through ESG. What is a PFX or PKCS12 file and how do I make one?

6. The FDA references digital signatures and Digital Certificates. What is the difference?

7. Where can I find a detailed guide on how to prepare my GlobalSign Digital ID for FDA ESG registration and submissions?

8. Which browser do you recommend I use?

9. Do you have any support videos on using PersonalSign Certificates for use with the FDA?

10. How to Renew or updating a Digital Certificate to an existing FDA ESG Account

11. Can Digital Certificates for the FDA ESG and Webtrader accounts be shared?

12. Preparing your certificate for the FDA ESG 

 

1. Who needs an FDA ESG Digital ID?

Any organization wishing to electronically submit one of the following to the FDA:

  • AERS – Adverse Event Reports

  • AERS Attachments

  • BLA – Biologics License Application (eCTD and eBLA format)

  • eCTD – Electronic Common Technical Document

  • H1N1 Lot Release

  • IDE – Investigational Device Exemption

  • IND – Investigational New Drug Application (eCTD and eIND format)

  • DMF – Drug Master File

  • Promotional Materials

  • Lot Distribution Data

  • AERS – Adverse Event Reports

  • AERS Attachments

  • ANDA – Abbreviated New Drug Application

  • BLA – Biologics License Application (eCTD and eBLA format)

  • eCTD – Electronic Common Technical Document (includes DMF - Drug Master File)

  • NDA – New Drug Application (eCTD and eNDA format)

  • IND – Investigational New Drug Application

  • Adverse Events

  • Electronic Submissions

See FDA- Table 2: Electronic Submissions Supported by the FDA ESG under the section 3.3 Understand Submission Guidelines.http://www.fda.gov/forindustry/electronicsubmissionsgateway/ucm334439.htm#3_3_1

 

 

2. The FDA tells me I need an X.509V3 Digital Certificate. What certificate should I choose?

GlobalSign Digital Certificates are perfectly suited for the FDA Electronic Submission Gateway as we offer Class 1 and Class 2 Certificates with 1-3 year validity periods. You can start your order here www.globalsign.com/en/fda-esg/. The FDA recommends a 3-year certificate validity which you can select as part of the ordering process.

For a detailed guide on ordering and installing your certificate, please visit our support site

 

3. The FDA guidelines references an option to create a self signed certificate using Adobe Acrobat. How does that work?

Self signed certificates are not legally binding as an independent certificate authority has not verified the contents of the digital ID.

 

4. I am on the FDA gateway site and section 4.1 Apply for a Test Account and Step 8: Locate the certificate file is asking me to Locate an X,509 Version 3 certificate file, where I must upload the certificate file to their website. "Enter the name of the certificate file to import. The file must have an extension of .cer, .p7b, or .p7c." What is the file name and where is it located on my computer, it did not say so during the registration process?

After completing your certificate installation using Internet Explorer, you can “export” your certificate to a local folder on your hard-drive. The certificate export process allows you to specify where you save the file and the name of the file. At completion of this step, you can then log into the FDA Electronic Submission Gateway (ESG) and “browse” to the file you previously saved. Exporting a Digital Certificate using Internet Explorer can be done via the following steps:

Step 1: From Internet Explorer go to Tools > Internet Options > Select the "Content" tab > Click on the "Certificates" button.

Step 2: Select your certificate in the Personal tab. Highlight the certificate and click View.

Step 3: To export the Certificate (.cer or .p7b) select Next on the next screen

Step 4: Select No, do not export the private key option and click on the Next button.

Step 5: Select the file extension. GlobalSign (Default DER encoded .cer is suitable)

Step 6: Browse for a folder you wish to save the Digital Certificate and name as you wish

See Section 4 http://www.fda.gov/forindustry/electronicsubmissionsgateway/ucm334439.htm#3_3_1 for setting up the test account and submitting test documents.

For additional details and screen shots, please reference our support article

 

5. After initial registration, the FDA requires me to put my certificate into a .PFX or PKCS12 format to actually submit electronically signed documents through ESG. What is a PFX or PKCS12 file and how do I make one?

PFX or PKCS12 is a “container” that includes the Digital Certificate and private key that is used to digitally sign the documents submitted through ESG. The ESG application needs to “point” to the file that you must create and save someplace on your local hard-drive. You can create a .PFX file by following the instructions found in GlobalSign’s FDA ESG end user guide under the section: To export private key (.pfx)

Step 1: From Internet Explorer go to Tools > Internet Options > Select the "Content" tab > Click on the "Certificates" button.

Step 2: Select your certificate in the Personal tab. Highlight the certificate and click View.

Step 3: Select yes, export the private key option and click on the next button.

Step 4: Select the option "Personal Information Exchange- PKCS #12 (.PFX) and check off "Include all Certificates in the Certification path if possible" & "enable strong protection"

Step 5: Create a password for your private key. Confirm the password and click the next button.

Step 6: Browse for a folder you wish to save the private key and name the file and click save

For additional details and screen shots, please see our support site.

 

6. The FDA references digital signatures and Digital Certificates. What is the difference?

A Digital Certificate is an electronic credential that binds an identity to a public and private key pair that is used to apply digital signatures. GlobalSign Digital Certificates are ideal for FDA ESG digital signatures since they bind both the signer and the signer’s organization to the submission. Since the identity has been vetted by strict guidelines specified in the GlobalSign Certificate Practice Statement, organizations can be assured the signature is legally binding.

 

7. Where can I find a detailed guide on how to prepare my GlobalSign Digital ID for FDA ESG registration and submissions?

Please consult our set of support articles

 

8. Which browser do you recommend I use?

Although both Internet Explorer and Firefox will work, GlobalSign recommends the use of Internet Explorer due to the additional certificate export steps required by the FDA.

 

9. Do you have any support videos on using PersonalSign Certificates for use with the FDA?

Our support article walks you through the steps of submitting a document to the FDA ESG.

 

10. How to Renew or updating a Digital Certificate to an existing FDA ESG Account

1. Renew (or obtain a new Digital Certificate) from GlobalSign

2. Export the public key and private key see. See our support articles for help if needed.

3. Email the public key (.cer) to esgreg@gnsi.com, providing the following information:

  • Primary account holder name
  • Electronic Submissions Gateway Account name

 

4. You will then receive a confirmation email from the FDA notifying you that the public key has been uploaded.

5. Once you have received a confirmation email, users may send submissions via the Electronic Submissions Gateway using the newly exported private key (.pfx)

 

11. Can Digital Certificates for the FDA ESG and Webtrader accounts be shared?

No, Digital Certificates can not be shared because they are associated with individual accounts. WebTrader accounts also can not be shared. Digital Certificates are associated with WebTrader accounts to establish the origin of a submission. Additional requirements:

  • FDA must be able to establish origin of a submission to supply electronic information for FDA review
  • Use of a PKI Digital Certificate and account name determines origin of the regulatory submission
  • PKI Digital Certificate utilizes public/private key exchange for encrypting and decrypting as the submission signature