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U.S. Department of Health and Human Services

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Setting up a WebTrader Account Checklist

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Checklist for Setting up a WebTrader Account with the FDA Electronic Submissions Gateway (ESG)

For policy questions and to request a WebTrader account, contact esgprep@fda.hhs.gov

For assistance with the registration or testing process, contact ESGHelpDesk@fda.hhs.gov.

Download a PDF version of this checklist.

 

For Electronic Drug Registration and Listing checklist, please see:
http://www.fda.gov/ForIndustry/ElectronicSubmissionsGateway/ucm177328.htm

For Center for Tobacco Products Registration checklist, please see:
http://www.fda.gov/ForIndustry/ElectronicSubmissionsGateway/ucm188949.htm

For Electronic Self-Identification of Generic Drug Facilities, Sites, and Organizations Instructions, Please see:
http://www.fda.gov/ForIndustry/ElectronicSubmissionsGateway/ucm320400.htm  

 

Request a WebTrader account

1. Send an email to esgprep@fda.hhs.gov requesting a WebTrader test account. Provide the following information:

  • Company name
  • First and Last Name
  • Phone Number
  • Submission Method: (WebTrader)
  • Indicate if you would like a WebTrader Hosted Solution (WTHS) account in addition to your WebTrader account. (For more information on WTHS accounts please click here).
Preparatory activities
2. Send a Letter of Non-Repudiation to FDA. Click here for more information on Non-Repudiation Letters.
Click here for additional steps pertaining to CROs, US Agents and Consultants.
3. Obtain a personal digital certificate. Click here for more information on certificates.
4. Prepare a guidance compliant test submission.  Each Center (CBER, CDER, etc.) has published guidance on the preparation of electronic submissions.  Refer to the specific center web site for information about guidance compliant submissions. If using FDA eSubmitter for the Center for Tobacco Products, you are not required to send a guidance compliant test submission.
5. Prepare a load test submission.  This submission need not be guidance compliant (the submission will not be reviewed by FDA), but should be representative of the file types you will be submitting in a typical submission (i.e., a mixture of PDF, text files, MS Word files, etc.) 
The load test requirements for each Center are:
  1. 2 GB submission for CBER or CDER

    If you foresee sending larger than a 2 GB submission to the FDA through ESG, then we strongly recommend that you submit a 7.5 GB Load Test submission.

  2. 2 GB submission for Center for Tobacco Products (load test is recommended if you expect your submission to exceed 2 GB)
  3. 1 GB submission for CDRH
  4. A load test is NOT required for CVM or OC (SPL submission)
6. Read the User Guide and tutorials on the FDA ESG web site. Review System Requirements.  Note: only Internet Explorer 6, 7, 8 and 9 are compatible with ESG.
Register Your Test Account
(for assistance contact ESGHelpDesk@fda.hhs.gov)
Wait for email with information on how to register online for a WebTrader test account.  (reply to email from Step 1)
7. Register for a WebTrader test account.  Follow the steps outlined in the email and refer to "Registering for a web based test account" tutorial for detailed registration steps.  You will need the public key for your personal digital certificate to complete this step.
Note: The Primary Contact must be a real person; the "Company Name" is actually an account name and must be unique throughout the entire ESG test system. We recommend appending the user's initials to your company name.
Wait for the WebTrader test account activation email. Account activation may take up to 48 hours.
Setup your machine/PC for ESG
8. Activation email received.
a. Install JRE and JCE. JRE and JCE Installation Instructions
b. Configure your firewall (activation email will contain the details)
Send Test Submissions
Log in to your ESG WebTrader test account (same URL to Register for a test account) with the user ID and password you created when you registered for your test account (step 7 above).
9. Send a small (20KB) text (.txt) file to the "Testing (GWTEST)" center with submission type "Connectivity Test". Refer to "sending a test submission" tutorial for detailed steps. Center for Tobacco Products submitters should send this test to "Center for Tobacco Products" center with submission type "Electronic Submission".
10. Send a guidance compliant test submission to the appropriate center (CBER, CDER, etc.) with appropriate submission type. See Item 4 above for more information. If using FDA eSubmitter for the Center for Tobacco Products, you are not required to send a guidance compliant test submission.
11. If you will be submitting a GDUFA Facility Registration, then you will need to submit a connectivity test to the GWTEST center using submission type of ConnectTest. Please perform step 11 only if you will be submitting to GDUFA. If you are not submitting to  GDUFA then continue on to the next step.
12. Send a load test to "Testing (GWTEST)" center and submission type "Size Test". See Item 8 above for more information.
The FDA will review your guidance compliant test submission, which may take up to 2 weeks.  You will be notified by the ESG staff by email regarding submission status.
Set Up a Production Account
13. Once you have sent all test submissions and the guidance compliant submission meets FDA requirements your account will be migrated to production. You will receive an email from ESG Helpdesk with production account confirmation and production URL
Log in to your ESG WebTrader production account with the same user ID and password you created when you registered for your test account (step 7 above).
You are now ready to send electronic submissions to FDA using the ESG system.

For policy questions and to request a WebTrader account, contact esgprep@fda.hhs.gov

For assistance with the registration or testing process, contact ESGHelpDesk@fda.hhs.gov

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