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.
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:
The current ESG supports submission through two main methods:
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.
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.
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:
Scalability and Availability:
Security:
The ESG NextGen will support submissions through three main methods:
The following is a high-level comparison of the current ESG functionality and the expected functionality of ESG NextGen (Source: FDA).
| Current ESG | ESG NextGen | |
|---|---|---|
| User Account Management | * Test then Production Account * Long turnaround time for account creation * Lack of enterprise ICAM solution |
* Comprehensive account provisioning workflow * Direct production account creation * Federated ICAM * Comprehensive account provisioning workflow * Direct production account creation |
| Package Preparation | * Client-side software installation required * Download & install may be blocked by company security policy * No auto-update if FDA changes form(s) |
* Web-based step-by-step submission preparation * In-page file upload * File size-based submission workflow * Incorporated Center submission wizards for a seamless user experience |
| File Submission | * Require digital certificate * No large file submission capability * Lack of transparent submission tracking * No integration w/ other FDA Center portals |
* eSignature to replace digital certificate * Improved file upload performance * Unified Submission Portal with status/tracking * API service * Large file submissions greater than 1 TB |
| Communication | * One-way user notification via acknowledgement | * Secure two-way user communication channel * Broadcast capability * Intelligent chatbot to improve user experience |
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
2024 Q3-Q4
2024 Q4 - 2025 Q1
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 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.
We are a US based company with Sri Lankan ingenuity majored in Cloud and Serverless technology based product engineering.
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