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Country Compliance

RegulatorsFda

FDA ties TRUE METRIX Safety Communication to Class I recall update

Relevant for
Local Safety OfficerSignal Management LeadRegulatory Intelligence LeadMedical Device Vigilance Lead+3 more
Action needed

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

Process impact
Signal ValidationLocal Affiliate ComplianceDevice Vigilance
SOP impact

7 SOPs may need review

Urgency: HighConfidence: medium
Read impact brief →
Country GuidesHealth Canada

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

Relevant for
Local Safety OfficerSignal Management LeadPV Quality LeadPV Technology / CSV Lead+2 more
Action needed

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

Process impact
Local Affiliate ComplianceInspection ReadinessRisk Management
SOP impact

5 SOPs may need review

Urgency: HighConfidence: medium
Read impact brief →
AI/GxPEma

MHRA reiterates GxP data integrity spans GVP as Annex 11 evolves

Relevant for
QPPVLocal Safety OfficerSignal Management LeadRegulatory Intelligence Lead+3 more
Action needed

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

Process impact
Local Affiliate ComplianceVendor OversightInspection Readiness
SOP impact

7 SOPs may need review

Urgency: HighConfidence: medium
Read impact brief →
Country GuidesMhra

UK MHRA refreshes PV procedures and adds decentralised manufacture UK GVP

Relevant for
Local Safety OfficerSignal Management LeadRegulatory Intelligence LeadPV Operations Lead+4 more
Action needed

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

Process impact
Signal ValidationRisk ManagementLocal Affiliate Compliance
SOP impact

9 SOPs may need review

Urgency: HighConfidence: medium
Read impact brief →

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