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Pharmacovigilance

publicEuropean Medicines Agency · European Union · Updated Jun 29, 2026

Regulatory Changes in Pharmacovigilance Data Management Following EMA's ISG Meeting

Urgency: High

MAHs must align their workflows to accommodate the updated requirements for signal management and ICSR submissions as per the discussions in the ISG meeting.

Signal ManagementICSRRegulatory Intelligence Lead
SOP Impact2 SOPs
ConfidenceHigh
Relevant for: Regulatory Intelligence Lead, Signal Management Lead
verifiedRegulatory action: Consultation / Forum
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