EU implementation strategy of ICH E2D (R1) Guideline – post approval safety data: definitions and standards for management and reporting of individual case safety report

The European Medicines Agency (EMA) has published the ICH E2D (R1) guidelines, which comes officially into effect in the EU on 18 March 2026. It includes instructions on its practical implementation for Marketing Authorisation Holders (MAHs), as well as National Competent Authorities and Inspectors.