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Country GuidesHealth Canada

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

Health Canada’s Q&A clarifies that Canada C.01.018 annual summary reports may be prepared in PSUR (ICH E2C(R1)) or PBRER (ICH E2C(R2)) format/content, supporting periodic benefit-risk appraisal and aggregate reporting alignment.

PV Impact Brief

Urgency: HighConfidence: medium
Relevant for
Local Safety OfficerSignal Management LeadPV Quality LeadPV Technology / CSV LeadAggregate Reports LeadQPPV
Processes impacted
Local Affiliate ComplianceInspection ReadinessRisk ManagementAI / GxP GovernanceAggregate Reporting
Action needed

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

Owner

Local Safety Officer

Review cadence

Immediate triage (within 1 business day), then weekly review until closure.

Evidence and confidence

Confidence: mediumSource update date not verified — confirm on the regulator site before acting

Primary-source confirmation recommended before operational implementation.

Full briefing

What changed

Health Canada’s Q&A clarifies that Canada C.01.018 annual summary reports may be prepared in PSUR (ICH E2C(R1)) or PBRER (ICH E2C(R2)) format/content, supporting periodic benefit-risk appraisal and aggregate reporting alignment.

Why it matters

Potential impact spans Local Affiliate Compliance, Inspection Readiness, Risk Management, AI / GxP Governance, Aggregate Reporting, so Local Safety Officer oversight is needed to maintain compliance readiness and evidence traceability.

Practical implication

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

#Aggregate Reporting#Country Compliance#Inspection Readiness#Health Canada#Country Guides#PBRER#PSUR#ICH

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