Issue Date: October 1, 2026
Issued by: Center for Drug Evaluation and Research
Topic(s): ICH-Efficacy
Status: Final
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
FDA has adopted the E2B(R3) data standards, and the documents on this guidance page reflect FDA’s recommendations for implementing them. The main document is the E2B(R3) Electronic Transmission of Individual Case Safety Reports (ICSRs) Implementation Guide — Data Elements and Message Specification; the Appendix I (B) Backwards and Forwards Compatibility (BFC) document is an appendix to the Implementation Guide. The page was refreshed in October 2026 with updated ICH ICSR XML Schema Set files and reference instances, and now lists Center for Biologics Evaluation and Research alongside Center for Drug Evaluation and Research as a co-issuing office.
Download the Guidance Document
