The FDA is modernizing how adverse event data are reported with the upcoming E2B(R3) implementation deadline. Beginning April 1, 2026, all Individual Case Safety Reports (ICSRs) must be submitted in the ICH E2B(R3) format. This update will transform pharmacovigilance operations by standardizing safety reporting and improving data accuracy. Companies that act now will avoid submission delays, validation errors, and compliance risks when the transition becomes mandatory.
Preparing for Transition: What You Need to Know About ICSR Compliance
What Is ICH E2B(R3)?
The International Council for Harmonisation (ICH) developed E2B(R3) to standardize how safety data are transmitted across global health authorities. It replaces the older E2B(R2) format with an XML-based structure for submitting Individual Case Safety Reports (ICSRs), ensuring consistency between regions like the FDA’s FAERS, EMA’s EudraVigilance, and Health Canada’s Vigilance Program. Each report includes harmonized data fields covering patient information, product details, event timelines, and outcomes, making it easier for regulators to automate safety monitoring and detect emerging risks more efficiently.
Key Regulatory Changes and Challenges
The FDA began accepting E2B(R3) submissions in 2024, but full compliance will be mandatory on April 1, 2026. During this transition, companies may still use E2B(R2), though early adoption is encouraged to minimize disruption. The shift introduces new challenges such as updating legacy systems to generate E2B(R3)-compliant XML files, mapping expanded data elements to meet FDA schema requirements, and aligning workflows between pharmacovigilance and regulatory teams. Organizations must also conduct testing and validation through the FDA’s Electronic Submission Gateway (ESG) to ensure readiness. Without proactive preparation, these requirements could lead to data rejection, reporting delays, or regulatory findings.
How Aquila Solutions Can Help
Aquila Solutions provides comprehensive support to sponsors preparing for E2B(R3) by combining regulatory expertise with hands-on publishing experience. Our team creates and validates compliant XML files for submission to FAERS and other international authorities, ensuring each case meets the latest schema and business rules. We guide clients through workflow redesigns, update internal SOPs, and provide training to help pharmacovigilance teams operate efficiently under the new standard. Whether clients need full outsourcing or temporary project support, Aquila manages case intake, XML generation, quality control, and submission delivery to maintain compliance without disrupting ongoing operations.
Preparing for 2026—Next Steps for Compliance
The E2B(R3) transition represents both a challenge and an opportunity for sponsors to strengthen safety operations ahead of the April 2026 deadline. Now is the time to assess systems, identify data mapping gaps, and initiate test submissions to confirm technical readiness. Collaboration between pharmacovigilance, IT, and regulatory publishing functions will be essential to achieve a smooth transition. Partnering with Aquila ensures early compliance and continuous support, allowing organizations to focus on product safety and innovation while we manage the technical and regulatory complexities of E2B(R3).
Aquila Solutions is ready to help your organization prepare for the FDA’s E2B(R3) implementation. Whether you need assistance generating XML files, validating safety submissions, or managing full pharmacovigilance workflows, our team ensures compliance every step of the way. Contact us today to discuss your transition plan and schedule a consultation.