FDA ESG: Guide to NextGen Submissions

The Electronic Submissions Gateway (ESG) is an agency-wide solution provided by the Food and Drug Administration (FDA) for securely accepting electronic regulatory submissions. This article focuses on the upcoming version of the ESG, known as ESG NextGen, exploring its key differences from the current ESG system and the expected advantages it will bring.

Electronic Submissions Gateway (ESG)

What is ESG?

As previously mentioned, the ESG is the FDA’s agency-wide solution for accepting electronic regulatory submissions. It enables secure submissions from industry partners, covering both premarket and postmarket regulatory information related to pharmaceutical entities such as drugs, clinical trials, medical devices, and more.

The ESG offers several capabilities that help streamline the processing of electronic submissions:

• Enables automatic processing of submissions in a secure environment.
• Serves as a single point of entry, acting as a conduit for all types of electronic submissions.
• Provides multi-level acknowledgments of receipt to the submitters.
• Routes and notifies the appropriate FDA center or office regarding the submissions.

Submissions to ESG

The current ESG supports submission through two main methods:

1. WebTrader: This is a web-based portal provided by the FDA with a locally installable add-on for file uploads. It is designed for low-volume submitters and offers a simple, user-friendly interface for easy submission of regulatory documents.

2. AS2 (Applicability Statement 2): This is a more advanced method where submitters use the well-established AS2 protocol to connect with the FDA. It is ideal for high-volume submitters and requires specialized AS2 software to handle the secure transmission of large volumes of data.

• Aayu Technologies’ AS2 Gateway is a reliable solution for regulatory submissions to the FDA ESG over AS2, and it is already trusted by some of the world’s largest pharmaceutical companies. This solution is specifically tailored with an easy-to-use web interface and can be deployed in your own data center or cloud environment using virtual machines or containers.
• Aayu Technologies’ MFT Gateway is also a cost-effective SaaS solution designed for regulatory submissions to the FDA ESG, offering as a low-maintenance solution ideal for small to medium companies.

ESG NextGen

As the name suggests, ESG NextGen is being developed as the next generation of the FDA’s ESG, featuring a modernized, cloud-based architecture. At a high level, the new solution aims to provide improvements in several key areas compared to the existing ESG, including:

Usability:

• A modernized user interface for a more intuitive experience.
• Capability to accept submission files up to Terabytes (TB) in size.
• Enhanced submission status tracking process for better visibility and updates.

Scalability and Availability:

• Enhanced scalability and availability to prevent disruptions or delays in submissions.
• Implementation of more robust disaster recovery mechanisms to ensure continuity and minimize downtime.

Security:

• Strengthened cybersecurity measures to protect the highly sensitive data included in submissions.
• Utilization of enterprise-grade Identity, Credential, and Access Management (ICAM) capabilities to ensure secure access and data protection.

Submissions to ESG NextGen

The ESG NextGen will support submissions through three main methods:

1. User Submission Portal (USP): This will be very similar in functionality and in usage to the “WebTrader” method provided by the current ESG.
2. AS2 (Applicability Statement 2): This will be the same as the “AS2” method of current ESG, where submitters use the well-established AS2 protocol to connect with the FDA.
3. API: This will be a brand-new method introduced by ESG NextGen, utilizing well-established RESTful standards to streamline the submission process. This method is still in the development or experimental stages. However, once finalized, it is anticipated to become the recommended method for submissions in the future.

Current ESG vs. ESG NextGen

The following is a high-level comparison of the current ESG functionality and the expected functionality of ESG NextGen (Source: FDA).

ESG NextGen Timeline

The following is the high-level timeline published by the FDA regarding the introduction of ESG NextGen and its anticipated production go-live:

2024 Q2

• Completion of ESG NextGen design
• ESG NextGen implementation and internal testing
• Planning user acceptance testing (UAT) with centers and the industry partners

2024 Q3-Q4

• ESG NextGen environment configurations
• Industry training and awareness
• Conducting user acceptance testing (UAT) with centers and the industry partners

2024 Q4 - 2025 Q1

• ESG NextGen completion and Go-Live

If you would like to gain a more in-depth understanding of upcoming ESG NextGen and its expectations, you can watch this webinar conducted by the FDA team for the industry partners.

Udith Gunaratna

Udith is the Chief Technology Officer at Aayu Technologies. With over 9 years of experience in the enterprise software industry, he has been instrumental in architecting, developing, and maintaining a range of enterprise software solutions, particularly B2B communication software, with a significant focus on cloud technologies.