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New EU Pharmacovigilance Requirements: What Regulation (EU) 2025/1466 Means for MAHs

📢 On 22 July 2025, the Regulation (EU) 2025/1466 amending Implementing Regulation (EU) No. 520/2012 was adopted. It introduces new pharmacovigilance (PV) requirements for EU-based MAHs, strengthening governance, transparency, and interoperability across PV processes.

🔹 Application timeline

  • 12 August 2025 → selected provisions apply (incl. EV database usage)
  • 12 February 2026 → full application of the regulation

✅ Key requirements include

  • clearer obligations for subcontracting and audit rights, including downstream 3rd parties
  • independent auditing to reinforce governance integrity
  • stronger MAH audits of their QMS
  • enhanced signal validation and notification protocols
  • streamlined PSMF – focus on major/critical deviations only
  • improved EV interoperability
  • extended PSUR content – must now include updates on RMM implementation
  • PASS registration in EMA’s electronic post-authorisation study register
  • DOI for literature – when available, DOI should be provided for ICSR reporting

💡 At MS Pharm, we will ensure readiness to support our customers – including providing DOIs for literature referencing in ICSR reporting.