Global PV updates, mapped to your role.

Local Safety OfficerSignal Management LeadRegulatory Intelligence LeadMedical Device Vigilance Lead+3 more

Fda update requires triage for Signal Validation, Local Affiliate Compliance, Device Vigilance; confirm local obligations and document follow-up actions.

Signal ValidationLocal Affiliate ComplianceDevice Vigilance

7 SOPs may need review

Country GuidesHealth CanadaSource date unverified: May 22, 2026

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

Local Safety OfficerSignal Management LeadPV Quality LeadPV Technology / CSV Lead+2 more

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

Local Affiliate ComplianceInspection ReadinessRisk Management

5 SOPs may need review

AI/GxPEmaSource date unverified: May 22, 2026

MHRA reiterates GxP data integrity spans GVP as Annex 11 evolves

QPPVLocal Safety OfficerSignal Management LeadRegulatory Intelligence Lead+3 more

Ema update requires triage for Local Affiliate Compliance, Vendor Oversight, Inspection Readiness; confirm local obligations and document follow-up actions.

Local Affiliate ComplianceVendor OversightInspection Readiness

7 SOPs may need review

Country GuidesMhraSource updated: Jun 10, 2025

UK MHRA refreshes PV procedures and adds decentralised manufacture UK GVP

Local Safety OfficerSignal Management LeadRegulatory Intelligence LeadPV Operations Lead+4 more

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

Signal ValidationRisk ManagementLocal Affiliate Compliance

9 SOPs may need review