FDA Final Guidance - Electronic Transmission of ICSRs

Learn the key updates from FDA’s October 2026 final guidance on E2B(R3) electronic transmission of Individual Case Safety Reports (ICSRs). This video breaks down what the guidance covers, why FDA is transitioning to E2B(R3), and what regulatory and pharmacovigilance teams must do to prepare. We cover: FDA adoption of the ICH E2B(R3) standard Mandatory transition requirements for postmarketing ICSRs New reporting destination: AEMS (replacing FAERS) ESG NextGen submission channel Scope of products impacted Operational implications for RA/PV teams A clear comparison of E2B(R2) vs E2B(R3) This content is designed for regulatory affairs, drug safety, and clinical compliance professionals who need a concise, accurate overview of FDA’s updated safety reporting expectations. Contains material © ICH. Used and adapted under the ICH public license.