The U.S. Food and Drug Administration (FDA) has strengthened its move toward the E2B(R3) standard for electronic submission of Individual Case Safety Reports (ICSRs) via the FDA Adverse Event Reporting System (FAERS). This initiative is part of the agency’s ongoing efforts to modernize pharmacovigilance and enhance global data exchange.
The latest update includes:
- Comprehensive technical guidance outlining FDA’s regional E2B(R3) implementation requirements.
- Business rules, validation criteria, and example XML files to help sponsors test and align their systems.
- Access to pre-production testing environments through the FDA Electronic Submissions Gateway (ESG).
- Extended transition timelines into 2026, allowing companies to adapt their systems and workflows.
The FDA’s shift to E2B(R3) ensures improved data quality, transparency, and interoperability in safety reporting. Sponsors and MAHs are urged to initiate testing early and ensure system readiness before full implementation.
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