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The FDA Electronic Submissions Gateway: Kicking Off the FDA Review Process

In today's fast-paced and technology-driven environment, ensuring the efficient exchange of information between regulatory agencies and the industries they oversee is crucial. One such initiative aimed at streamlining communication and enhancing transparency is the FDA's Electronic Submissions Gateway (ESG). This blog will delve into the history and purpose of the ESG, how the FDA utilizes this platform, and outline the steps involved in registering for the gateway. Furthermore, we will discuss the benefits and challenges of using the ESG.

History and Purpose of the Electronic Submissions Gateway

The ESG was launched in 2006 as a response to the growing need for a more efficient and secure electronic submission system for industries regulated by the FDA. The initiative was driven by the FDA's commitment to modernizing its regulatory processes and promoting digital transformation.

One of the key milestones leading to the ESG's development was the FDA's 1999 "Guidance for Industry: Providing Regulatory Submissions in Electronic Format." This guidance document encouraged the industry to adopt electronic submissions, setting the stage for a more streamlined and paperless submission process. Subsequently, the electronic common technical document (eCTD) evolved as a submission standard. The most recent guidance, “Providing Regulatory Submissions in Electronic Format — Certain Human Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications, Guidance for Industry,” was published on February 7, 2020 (Rev. 7).

In 2003, the FDA introduced the "Guidance for Industry: Part 11, Electronic Records; Electronic Signatures – Scope and Application." This guidance clarified the use of electronic records and signatures, further paving the way for the ESG's implementation.

The primary goal of the ESG is to provide a centralized, secure, and efficient channel for electronic submissions, reducing the need for paper-based documents and speeding up the review process. The ESG serves as a conduit for various types of submissions, including drug applications, medical device reports, and food safety notifications, among others. By consolidating these submission processes into one platform, the ESG streamlines communication between the FDA and regulated industries, fostering a more collaborative and transparent regulatory environment.

The Office of the Commissioner, as part of the U.S. Food and Drug Administration (FDA), also uses the FDA Electronic Submission Gateway (ESG) to streamline the submission and review process for Structured Product Labeling (SPL) documents. The FDA ESG and SPL submissions provide a clear record of compliance with regulatory requirements, allowing the Office of the Commissioner to monitor and enforce adherence to labeling standards, safety protocols, and other regulations.

In 2016, Health Canada implemented and began accepting electronic submissions through the FDA’s ESG. The move to electronic submissions was part of Health Canada's overall efforts to modernize and streamline its regulatory processes and align with global standards for electronic regulatory submissions. Prior to implementing the ESG, Health Canada had accepted electronic submissions through other secure electronic portals, but the use of the FDA ESG provided a standardized and more efficient method for submitting electronic regulatory information.

The FDA’s Electronic Submission Receipt Process

Once a submission is received through the FDA's Electronic Submissions Gateway (ESG), it undergoes a multi-step process that includes validation, routing, review, and decision-making.

Validation of Electronic Submissions

After the submission is received, the ESG performs a series of checks to ensure the submission's format, structure, and content comply with the FDA's requirements. If any issues are detected, the submitter is notified and asked to correct them before resubmitting. This validation process helps identify errors, inconsistencies, or missing information that could hinder the review process.

The FDA's technical validation criteria define the set of requirements that a submission must meet for successful acceptance and processing through the ESG. These criteria ensure that submissions are compliant with the FDA's established standards for format, structure, and content, thus streamlining the review process and minimizing delays.

When a submission is received, the ESG performs a series of automated checks based on these criteria to identify any issues or discrepancies. Some technical validation criteria include proper file formats, electronic signatures, metadata, and folder and file naming conventions. If a submission fails to meet the technical validation criteria, it may be rejected by the ESG. The submitter will be notified with an explanation of the errors that must be addressed before resubmission.

Routing Electronic Submissions to the Appropriate Review Division

Upon successful validation, the submission is electronically routed to the appropriate FDA center and the specific review division responsible for reviewing that type of submission. Sponsors receive an acknowledgment indicating that the submission was successfully processed and is available to the assigned review division.

Agency Review of Electronic Submissions

Once the submission reaches the relevant review division, a team of experts, including scientists, medical officers, and other subject matter specialists, reviews the data and evaluates the safety, efficacy, and quality of the product or process under review. This comprehensive assessment is crucial for determining whether the submission meets the FDA's regulatory standards and requirements.

Using the ESG to Submit Electronic Regulatory Submissions

The FDA Electronic Submission Gateway (ESG) provides two options for submitting electronic submissions to the FDA: WebTrader and AS2.

WebTrader is a web-based application that allows users to submit documents in electronic format. WebTrader provides a simple, user-friendly interface for uploading and submitting electronic documents to the FDA. WebTrader supports a variety of submission types, including electronic common technical document (eCTD) submissions, non-eCTD electronic submissions (NeeS), and submissions of individual PDF documents.

AS2 is a more advanced method of submitting electronic submissions to the FDA. AS2 uses a secure, encrypted connection to transfer files between the sender and recipient. AS2 requires more technical knowledge and expertise to set up and use compared to WebTrader, as it involves configuring the sender and recipient systems to communicate via a secure AS2 connection.

You can read more about the FDA’s ESG on its website.

WAYS Experience Using the FDA ESG

The WAYS team uses the FDA ESG on behalf of our clients. We use the ESG system daily. If you are preparing to submit your first electronic submission, contact WAYS to understand how we can simplify the process – from organizing and publishing the submission to supporting the entire submission lifecycle. It’s what we do, and we do it well every day.

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