The EMA has introduced key pharmacovigilance updates impacting all EU MAHs. GVP Module VI Addendum II (July 2025) mandates masking of personal data in ICSRs submitted to EudraVigilance to align with data-protection laws. Implementing Regulation (EU) 2025/1466 (effective August 2025–February 2026) strengthens oversight of outsourced PV activities, enhances signal management, and mandates active use of EudraVigilance data. All ICSRs must follow ICH E2B(R3) and updated XEVMPD product data standards. MAHs must update PV systems, SOPs, and validation pipelines to support selective data masking, maintain metadata integrity, and ensure readiness for upcoming compliance deadlines across EU pharmacovigilance operations.
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