PV Bulletin

Category

Regulators

Regulatory intelligence from FDA, EMA, MHRA, and global agencies — guidance changes, committee outcomes, and pharmacovigilance policy updates.

publicFda · Updated May 22, 2026

FDA ties TRUE METRIX Safety Communication to Class I recall update

Urgency: High

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

Signal ValidationLocal Affiliate ComplianceLocal Safety Officer
SOP Impact7 SOPs
ConfidenceMedium
Relevant for: Local Safety Officer, Signal Management Lead, Regulatory Intelligence Lead
verifiedRegulatory action: Regulators
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publicHealth Canada · Updated May 22, 2026

Health Canada reposts device recall forms and updates GVP GUI-0102

Urgency: High

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

Local Affiliate ComplianceDevice VigilanceLocal Safety Officer
SOP Impact4 SOPs
ConfidenceMedium
Relevant for: Local Safety Officer, Regulatory Intelligence Lead, Medical Device Vigilance Lead
verifiedRegulatory action: Regulators
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publicTga · Australia · Updated May 22, 2026

TGA safety updates add warnings for GLP-1s, fluoroquinolones, RSV vaccines

Urgency: Medium

Tga update requires triage for Label Governance, Signal Validation, Risk Management; confirm local obligations and document follow-up actions.

Label GovernanceSignal ValidationLocal Safety Officer
SOP Impact6 SOPs
ConfidenceMedium
Relevant for: Local Safety Officer, Signal Management Lead, Labeling Lead
verifiedRegulatory action: Regulators
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