Date of Publication: 23-Feb-2026
INTELLIGENCE OVERVIEW
Agency: EMA
The European Medicines Agency (EMA) has published an updated list of reference documents supporting electronic safety reporting to the EudraVigilance system. This resource outlines essential guidance, technical specifications, and regulatory requirements for submitting Individual Case Safety Reports (ICSRs) in the European Union pharmacovigilance framework.
The documents include standards aligned with International Council for Harmonisation E2B(R3), reporting requirements, terminology standards, and implementation guidance for marketing authorisation holders and sponsors. These references help ensure accurate, timely, and compliant electronic reporting of adverse events.
This update highlights the importance of maintaining compliant pharmacovigilance systems aligned with EMA and ICH standards. Companies must ensure their reporting processes meet EudraVigilance requirements to support regulatory compliance, improve safety monitoring, and enhance patient safety.
KEYWORDS: Pharmacovigilance System, Adverse Event Reporting, Electronic Submission
REFERENCE: https://www.ema.europa.eu/en/documents/other/electronic-reporting-eudravigilance-list-reference-documents_en.pdf