In April of this year, the FDA Adverse Event Reporting System (FAERS) finalized the new process for submitting required safety reports through the Electronic Submissions Gateway (ESG).
FAERS was implemented to consolidate multiple disparate reporting systems currently used across all FDA-regulated product categories, including medical products, vaccines, devices, tobacco, food, cosmetics, and veterinary medicines. The unified platform is designed to enhance data quality and consistency through standardized reporting protocols, streamline reporting processes to reduce administrative burden on both internal FDA staff and external stakeholders, and strengthen safety surveillance capabilities through advanced case processing workflows, AI-based redaction and digitization tools, enhanced analytics, and comprehensive cross-product surveillance.
With the change in April, Individual Case Safety Report (ICSR) submissions are submitted in the ICH E2B(R3) format directly to FAERS. ICSRs are integrated reports that describe adverse events or reactions associated with FDA-regulated products. These reports serve as the primary data unit for pharmacovigilance, and they monitor drug safety profiles throughout a product lifecycle.
The FDA is no longer accepting the legacy format filings as of the April 1, 2026 mandatory compliance deadline. Transitioning from legacy E2B(R2) format to this granular XML-based structure enables unified safety surveillance and enhanced signal detection.
The previous submission method involved processing PDFs of the report(s) in eCTD format using publishing software to create an output capable of being sent through the ESG. Submitting this way also required inclusion of Form 1571 and a Cover Letter along with the report. While these are relatively simple steps, the amount of time needed to fully process and upload a submission often seemed unnecessarily complex.
The new method requires only one item: the XML file associated with the report. This file does not need to be processed through publishing software, thereby eliminating the need for additional files in the submission. E2B(R3) is the latest electronic standard for submissions of ISCRs. It was developed by the ICH in collaboration with Standards Development Organizations, and improves data granularity, enhances interoperability, and allows for embedded attachments for things like medical records and images.
E2B(R3) is codified as ISO 27953-2:2011 and utilizes HL7 Version 3 messaging for a structured XML framework. The process is straightforward: upload the XML to CEDR via ESG’s NextGen Unified Submission Portal as the type “AERS_PREMKT_CDER”. You receive an initial Acknowledgement (ACK1) as well as the final Acknowledgement (ACK3).
This transition impacts various stakeholders throughout industry, including domestic and foreign sponsors submitting clinical trials under an IND application, marketing authorization holders like manufacturers for approved NDAs, ANDAs, and BLAs, and third-party service providers such as CROs, IT vendors, and regulatory consultants managing safety databases and gateways. A few different reports are impacted, including post-market ISCRs, inclusive of expedited 15-day and non-expedited reports for CDER and CBER regulated products, premarket IND Safety Reports that cover serious or unexpected adverse reactions in trials under an IND, and IND exempt BA/BE reports that cover serious adverse events from bioavailability or bioequivalence studies. Note however that not all IND safety reports qualify for the E2B(R3) XML change; reports detailing animal or in vitro testing results, findings from other studies, or observations of increased incidence rates still require eCTD submission. The standardized XML fields cannot fully capture the contextual narrative explanation and study interpretation necessary in those specific reports. Here at GLOBAL, we are well versed in these changes and can support your organization in updating your submission and all related reports to meet the standards.
This change improves regulatory alignment, reducing duplication of effort and supporting a unified approach to global regulatory compliance. While there are some challenges in making the shift, including ensuring your software or IT is upgraded to meet the specific needs of integration, training your team to navigate the requirements, and understanding the nuances of the ESG pathway, ultimately the changes will create more ease and clarity in the submission process.
Connect with us today to see how GLOBAL can help your organization make this shift and keep your submissions on time and compliant.
In April of this year, FAERS finalized the new process for submitting required safety reports through the Electronic Submissions Gateway (ESG). Read more for how this affects regulatory publishing.
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