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8 Easy Steps to Establish an Electronic Submissions Gateway (ESG) Account with the FDA

April 16, 2015 | Jacquie Powell, PhD, Clinical Research Scientist | Regulatory Operations

In a previous post, we outlined the upcoming requirements for electronic submissions. In this post, we’ll show you how to set up an account for submitting regulatory documents electronically via the FDA’s Electronic Submissions Gateway (ESG, aka the Gateway).

What is the Gateway?
The ESG is a portal that facilitates communication between the FDA and the pharmaceutical industry by providing a secure digital environment to submit regulatory documents for review.

The ESG can either be accessed through the internet, using the WebTrader interface, or via an AS2 Gateway‑to‑Gateway connection. Many small to midsized companies find the WebTrader system preferable because it uses a standard internet browser and is relatively inexpensive, while larger companies often use the Gateway-to-Gateway connection.

How to access the ESG through WebTrader is the focus of this post but more information about setting up an AS2 Gateway‑to‑Gateway connection can be found here.

What are the benefits of using the Gateway?

The ESG eliminates the hassle and expense of printing and shipping physical documents by serving as an electronic delivery system for submissions to arrive at their final destination.

While the ESG does not allow FDA reviewers to directly open or review submissions, it automatically routes them to the appropriate FDA center or office, providing direct notification to the appropriate individuals within the FDA as well as an acknowledgement of receipt to the sender.

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Image courtesy of David Castillo Dominici at FreeDigitalPhotos.net

This process saves time compared with old-fashioned paper submissions and provides assurance that the appropriate FDA division is alerted when new submissions are available for review.

Aside from the convenience of digitally sending regulatory submissions to the FDA, the ESG is becoming standard practice in the industry. Each year since 2006 the FDA has experienced a dramatic increase in the number of ESG submissions, with a greater than 35-fold increase between 2006 (58,664 submissions) and 2014 (2,100,772 submissions).

So, for regulatory professionals to stay current, a working knowledge of ESG submissions is becoming essential.

Plan ahead for first-time submissions via the Gateway
Gaining access to the ESG is a multistep process that’s too important to rush. Based on our experience, we’d recommend setting up your account at least 2 months before the due date for your first electronic submission.

Here are 8 easy steps for setting up your own ESG account:

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8 Easy Steps for Setting Up Your ESG Account with the FDA

Step 1: Obtain a digital certificate

The FDA requires that an X.509 (Version 3) digital certificate be obtained before registering for an FDA ESG account.

A digital certificate is an electronic document that uniquely authenticates its owner’s identity and there are a number of companies such as GlobalSign, Comodo, or GeoTrust that sell digital certificates after thoroughly verifying a customer’s identity.

Allow at least 1 to 2 weeks for this process and be prepared to verify both your identity and that of your company.

Step 2: Submit a non-repudiation letter

To ensure that your digital certificate and password combination is legally binding, a non‑repudiation agreement must be physically signed and sent to the FDA before registering for an FDA ESG account.

Step 3: Apply for a test ESG account

A temporary login ID and password for the ESG web interface can be obtained by sending an e-mail to the FDA requesting a test account.

Once logged in, a registration wizard guides new users through the ESG application, which requires importing a digital certificate, providing company information, and selecting an FDA center to route future submissions.

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Image courtesy of thanunkorn at FreeDigitalPhotos.net

New users can create their own personalized ESG credentials at the end of the registration process, which are confirmed by the FDA via e-mail.

Step 4: Set up your computer

To use WebTrader, your computer will need to meet specifications set by the FDA. Ensuring that your computer has the correct internet browser, Java version, and amount of memory are critical for successfully launching and navigating the WebTrader interface.

Step 5: Create test submissions

Test submissions are performed to make sure that everything, including both the computer and web interface account, has been set-up properly.

The FDA requests that you send 3 types of test submissions during the testing process, which are described in Step 6.

  • A very small text message, about a sentence in length, for the connectivity test.
  • A compliant eCTD, for the compliant submission test.
  • A large submission that is at least 2GB in size for the load test.

Step 6: Send test submissions

The FDA requires 3 types of submission tests, described below.

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  • A connectivity test ensures that your Gateway connection is working properly and involves sending a small text message to the “Testing” center through the ESG main menu.
  • A compliant submission test is sent to the specific center where you will be sending electronic submissions. After receiving the center’s approval, you will be given a production account.
  • A load test is performed to make sure that you can send large files through the Gateway.  For example, CDER and CBER request that you send a 2 GB submission to the “Testing” center before your first official submission.

Detailed instructions for sending test submissions are provided on the FDA website.

Step 7: Wait for FDA confirmation of approval

After you have performed the required submission tests, it may take several weeks for the FDA to send an e-mail approving your account for use. Based on our experience, we suggest waiting 3 weeks before sending the FDA a follow-up e-mail if you have not received their approval following the completion of your submission tests.

Step 8: Production account is ready for use

Once a production account is approved, users are authorized to send electronic submissions through the ESG.

Important Considerations
Individual ESG user accounts cannot be associated with more than one company, so contract research organizations (CROs) need to create separate accounts for each sponsor. Conversely, if multiple ESG user accounts are affiliated with the same company, each user will need to use a slightly different username (for example: BigPharma-A, BigPharma-B).

It takes time and a lot of digital memory to send large electronic submissions through the ESG, so plan accordingly. All submissions greater than 7.5GB should be sent to the FDA after 4:30PM for overnight transmission. Also, remember to delete any backup files generated during the ESG submission process to free-up precious hard drive space.

Need Help?
IMPACT has a Regulatory Operations group with extensive experience submitting FDA documents via the ESG. If you would like to discuss your specific needs in detail, please contact us or give IMPACT a call today at (919) 899-9248. We’d be happy to assist you!

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Category: | Regulatory Operations
Keywords: ESG, Electronic Submissions Gateway, WebTrader

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