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EU Pharmacovigilance: Implementing Regulation (EU) 2025/1466

Regulatory Affairs Pharma & Biotech
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Almudena del Castillo, Country Manager Spain & Head of Global Vigilance Division at QbD Group

The European Commission has amended Regulation (EU) No 520/2012 on pharmacovigilance. The update strengthens oversight of outsourced PV activities, clarifies EudraVigilance monitoring, and aligns processes with international data standards (IDMP, MedDRA, Standard Terms).

EU Pharmacovigilance: Implementing Regulation (EU) 2025/1466 | QbD Group
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Key updates

 

PV outsourcing

Contracts must define roles, data exchange, audit/inspection rights, and prohibit onward subcontracting without written consent. Third parties must accept audits and may be inspected by regulators.

Audits

Risk-based audits must cover all PV activities, including subcontracted work.

EudraVigilance

MAHs must monitor EV alongside other sources; authorities must monitor EV continuously. Signals needing further analysis must be confirmed within 30 days.

Data & reports

Updated requirements for ICSR minimum elements, literature references (with DOI), PSURs (RMM implementation/effectiveness), and PASS registration in EMA’s PAS register.

PSMF

Focus only on major/critical deviations, their impact, and resolution.

 

What does this mean to you?

This amendment closes long-standing operational gaps: it codifies what many inspectors already expect on third-party control, tightens signal management timelines, and pushes convergence with IDMP and robust RMM effectiveness reporting. MAHs should update contracts, refresh audit plans, and adapt SOPs for EV monitoring and reporting.

Changes take effect from 12 February 2026, so preparations should begin now.

 

 

CTA RA update pharma

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