Electronic Submission of Postmarketing Individual Case Safety Reports to the FDA Adverse Event Monitoring System Using ICH E2B(R3) Data Standards
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The FDA is updating its data standard requirement for electronic submission of postmarketing Individual Case Safety Reports (ICSRs) for human drugs, biological products, and combination products. Beginning October 1, 2026, all ICSRs submitted through the Electronic Submissions Gateway NextGen (ESG NextGen) to the FDA Adverse Event Monitoring System (AEMS) must use the ICH E2B(R3) data standards instead of the previous E2B(R2) format. FDA will stop accepting E2B(R2) submissions after September 30, 2026. The new standard improves data quality with new and expanded data elements, event-level seriousness assessment, and embedded attachments. Submissions through the Safety Reporting Portal (SRP) are not affected by this requirement.
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Key Changes
- Mandatory use of ICH E2B(R3) data standards for ESG NextGen ICSR submissions starting October 1, 2026
- FDA will no longer accept ICH E2B(R2) format submissions after September 30, 2026
- Transition period ends after two years of voluntary E2B(R3) acceptance that began in January 2024
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