Electronic Self-Identification of Generic Drug Facilities, Sites, and Organizations Instructions
Helpful Contact Information
For GDUFA Guidance and more information on the electronic self-identification process please see Generic Drug User Fee Amendments of 2012 web site, at http://www.fda.gov/forindustry/userfees/genericdruguserfees/default.htm
|Request a WebTrader account|
|1. Send an email to email@example.com requesting a WebTrader test account. Provide the following information: Company name, your name, phone number and submission method (WebTrader). Click here for more information on the Email Policy.|
|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. Please refer to the GDUFA Guidances web page and the Structured Product Labeling Resources web page for more information on how to prepare SPL documents.|
|5. Read the User Guide and tutorials on the FDA ESG website. Review System Requirements. Note: only Internet Explorer 6, 7, 8, and 9 are compatible with ESG.|
|Register Your Test Account|
(for technical 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)|
|6. 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 you personal digital certificate (refer to step 3) 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 |
|7. Activation email received. Follow the instructions outline in the email to:|
|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 6 above).|
|8. 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.|
|9. Because CDER and CBER submissions are housed in separate data repositories, there are different submission instructions for both FDA Centers. To send a guidance compliant test submission, review the instructions below:|
• For CDER submissions, submit your SPL submission to the ‘CDER’ center with the submission type as, ‘GDUFA Facility Registration’.
• For CBER submissions, submit your SPL submission to the ‘OC’ center with the submission type as, ‘SPL’.
|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|
|10. Once you have sent all test submissions and the guidance compliant submission meets FDA requirements, you will be sent an email with information on how to register for a production account.|
|11. Register for production WebTrader account following the steps outlined in the email. You will need the public key for your personal digital certificate to complete this step.|
|Wait for the WebTrader production account activation email. Account activation may take up to 48 hours.|
|13. Activation email received for the Production Account. Follow the instructions in the activation email.|
|a. You must use the same computer that you used for testing.|
|b. Make sure you have the JRE and JCE installed.|
|c. Configure your firewall (activation email will contain the details)|
|Log in to your ESG WebTrader production account (same URL to register for a production account) with the user ID and password you created when you registered for a production account (step 13 above).|
|You are now ready to send electronic submissions to FDA using the ESG system.|
For questions relating to the content of CDER Generic Drug Facility Electronic Self-Identification SPL submissions, contact CDEReFacility@fda.hhs.gov.
For questions relating to the content of CBER Generic Drug Facility Electronic Self-Identification SPL submissions, contact firstname.lastname@example.org.
For policy questions and to request a WebTrader account, contact email@example.com.
For technical assistance with the registration or testing process, contact ESGHelpDesk@fda.hhs.gov.