Primary source: Health Canada (Canada.ca)
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.
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.
Health Canada update requires triage for Local Affiliate Compliance, Inspection Readiness, Risk Management; confirm local obligations and document follow-up actions.
Local Safety Officer
Immediate triage (within 1 business day), then weekly review until closure.
Primary-source confirmation recommended before operational implementation.
Health Canada update requires triage for Local Affiliate Compliance, Inspection Readiness, Risk Management; confirm local obligations and document follow-up actions.
Health Canada published a Q&A (03 Sep 2024) clarifying that Market Authorization Holders (MAHs) can fulfill the annual summary report preparation requirement under Food and Drug Regulations C.01.018 using either a Periodic Safety Update Report (PSUR) or a Periodic Benefit-Risk Evaluation Report (PBRER), provided the report’s format and content align to the relevant ICH guidance (E2C(R1) for PSUR; E2C(R2) for PBRER).
For PV and regulatory operations, this is an evergreen compliance clarification with practical impact on how Canada periodic reporting is planned, documented, and defended under inspection readiness expectations. The Q&A frames the purpose of the associated Notice as informing MAHs that Health Canada will accept these ICH-aligned report formats for the C.01.018 annual summary report requirement.
The Q&A also describes what Health Canada expects a PBRER to represent: a periodic, comprehensive, concise and critical analysis of new or emerging risk information and benefits in approved indications, intended to enable appraisal of the product’s overall benefit-risk profile.
Because the Q&A explicitly ties acceptability to the ICH E2C revision associated with the chosen report type, PV teams should confirm the Canada annual summary report approach (PSUR aligned to ICH E2C(R1) vs PBRER aligned to ICH E2C(R2)) and ensure the corresponding controlled template(s) and QC checklist(s) match the selected format/content.
PV Quality, Regulatory Intelligence, and Aggregate Reporting teams may also wish to update controlled documents (SOPs, work instructions, templates, and report calendar notes) to reflect Health Canada’s acceptance statement for Canada compliance positioning, and ensure an inspection-ready justification is available for the chosen format.
The Q&A references a separate “Notice” in describing its purpose, but that Notice content is not included in the provided evidence; any additional operational details (such as transition timing, submission mechanics, or scope nuances) cannot be confirmed from this source extract.
Apply this clarification before the next Canada annual summary report cycle and monitor the Health Canada Q&A page for revisions or linked Notice updates; for upcoming C.01.018 deliverables, confirm the PSUR vs PBRER approach and lock the selected ICH-aligned format into templates, QC checks, and controlled documents for Canada compliance and inspection readiness.
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