International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use Route Pré -Bois 20, P.O Box 1894, 1215 Geneva, Switzerland Telephone: +41 (22) 710 74 80- admin@ich.org, http://www.ich.org ICH E2B(R3) Expert Working Group / Implementation Working Group ICH E2B(R3) Guideline : Electronic Transmission of Individual Case Safety Reports (ICSRs) Questions and Answers V ersion 2.4 17 January 2023