Commission Implementing Regulation (EU) 2025/1466 introduces updated pharmacovigilance requirements aimed at strengthening regulatory oversight, improving patient safety, and enhancing the consistency of pharmacovigilance activities across the European Union. The regulation reinforces expectations for Marketing Authorization Holders (MAHs) in key areas, including Pharmacovigilance System Master File (PSMF) management, risk-based pharmacovigilance audits, signal management, periodic safety reporting, and oversight of outsourced pharmacovigilance activities.
As the regulation is now being implemented, MAHs should review their pharmacovigilance systems, standard operating procedures, quality management processes, and vendor governance frameworks to ensure compliance with the updated requirements. Organizations that proactively address these changes can strengthen inspection readiness, improve operational efficiency, and maintain compliance with evolving EU pharmacovigilance expectations.
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