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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 →
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 →
LatestEma

MaaT Pharma flags CHMP “negative trend” ahead of June vote

Relevant for
Signal Management LeadLabeling LeadRegulatory Intelligence LeadPV Technology / CSV Lead+2 more
Action needed

Ema update requires triage for Label Governance, Risk Management, AI / GxP Governance; confirm local obligations and document follow-up actions.

Process impact
Label GovernanceRisk ManagementAI / GxP Governance
SOP impact

5 SOPs may need review

Urgency: MediumConfidence: medium
Read impact brief →

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Current context: role PV Technology / CSV Lead, workflow Risk Management.