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 your 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 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 6 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.