PV Bulletin

Tag archive

ICH

publicHealth Canada · Updated May 22, 2026

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

Urgency: High

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

Local Affiliate ComplianceInspection ReadinessLocal Safety Officer
SOP Impact5 SOPs
ConfidenceMedium
Relevant for: Local Safety Officer, Signal Management Lead, PV Quality Lead
verifiedRegulatory action: Country Guides
Read impact briefarrow_forward

Get updates for your PV role

Subscribe to impact-first pharmacovigilance updates. Select every role you want in your digest.

Digest roles: QPPV. Work email only