EMA guidance on masking personal data in Eudravigilance reports
The European Medicines Agency (EMA), in collaboration with the Heads of Medicines Agencies (HMA), has issued an addendum to its good pharmacovigilance practices (GVP) guidelines, specifically addressing the masking of personal data in individual case safety reports (ICSRs) submitted to EudraVigilance. This update follows an audit by the European Data Protection Supervisor, which highlighted the need for a unified masking policy across all entities reporting to EudraVigilance. The addendum outlines which data elements should be masked, left blank, or retained based on their relevance to pharmacovigilance processes such as signal management, duplicate detection and case processing.