publicEuropean Medicines Agency · European Union · Updated Jun 29, 2026
Regulatory Changes in Pharmacovigilance Data Management Following EMA's ISG Meeting
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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