E2B (R3) is an ICH international standard that defines the data elements and electronic format for transmitting Individual Case Safety Reports (ICSRs) between sponsors and regulators.
E2B (R3) standardizes how adverse event and serious adverse event information is structured for electronic exchange. It supports consistent safety case processing across systems, vendors, and global health authorities. Implementing E2B (R3) enables efficient regulatory reporting and improves data interoperability for pharmacovigilance. The standard is foundational for compliant electronic safety reporting workflows and cross-region submissions.