FDA Drugs (New Approvals & NDA)Original article
E2B(R3) Electronic Transmission of Individual Case Safety Reports Implementation Guide — Data Elements and Message Specification; and Appendix to the Implementation Guide — Backwards and Forwards Compatibility
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Summary
The International Council on Harmonisation released guidance on E2B(R3) electronic transmission specifications for individual case safety reports, establishing data elements and message standards with backwards and forwards compatibility considerations.
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regulatoryimplementation guideICHdata standardscase safety reports
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Published by FDA Drugs (New Approvals & NDA) on September 30, 2026 7:40 PM