Country Guides

Country pharmacovigilance requirements, QPPV obligations, EU QPPV, reporting timelines, and local affiliate compliance guides.

publicHealth Canada · Updated May 22, 2026

Health Canada Q&A accepts PSUR or PBRER for C.01.018 reports

Urgency: High

Health Canada update requires triage for Local Affiliate Compliance, Inspection Readiness, Risk Management; confirm local obligations and document follow-up actions.

Local Affiliate ComplianceInspection ReadinessLocal Safety Officer

SOP Impact5 SOPs

ConfidenceMedium

Relevant for: Local Safety Officer, Signal Management Lead, PV Quality Lead

verifiedRegulatory action: Country Guides

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publicMhra · Updated Jun 10, 2025

UK MHRA refreshes PV procedures and adds decentralised manufacture UK GVP

Urgency: High

Mhra update requires triage for Signal Validation, Risk Management, Local Affiliate Compliance; confirm local obligations and document follow-up actions.

Signal ValidationRisk ManagementLocal Safety Officer

SOP Impact9 SOPs

ConfidenceMedium

Relevant for: Local Safety Officer, Signal Management Lead, Regulatory Intelligence Lead

verifiedRegulatory action: Country Guides

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