E2B

E2B is the International Council for Harmonisation (ICH) standard for the electronic transmission of Individual Case Safety Reports (ICSRs) in pharmacovigilance.

E2B is the critical technical standard (ICH M1) that mandates the format, content, and structure for electronically exchanging drug safety data globally. The current iteration, E2B(R3), specifies the XML message structure and over 100 data elements: patient demographics, adverse event details, and product information. This standard ensures pharmaceutical companies and regulatory bodies—like the FDA and EMA—can transmit ICSRs (Individual Case Safety Reports) efficiently through secure electronic gateways, facilitating rapid analysis and signal detection to protect public health.

https://www.ich.org/page/ich-e2b-r3-individual-case-safety-report-icsr-specification-and-related-files