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Risk Management

Country GuidesHealth CanadaCanada

Health Canada updates RMP submission guidance effective 1 July 2025

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

1) Retrieve and review the updated “Submitting risk management plans guidance document” (PDF) and linked templates referenced from the overview (e.g., RMP note to reviewer, Canadian-specific addendum, RMP summary template) and map deltas vs the superseded 2015 approach. 2) Update Canada submission checklists/work instructions for the 1 July 2025 effective date, including the requirement that the RMP include a summary in English and French and use of the RMP summary attestation/acknowledgment form. 3) Ask Regulatory Intelligence/RA to brief PV leadership on the Agile Licensing notice timeline (RMP provisions in force 1 April 2027) and confirm how transitional provisions will be operationalized for existing RMPs submitted prior to that date.

Process impact
Label GovernanceRisk ManagementLocal Affiliate Compliance
SOP impact

5 SOPs may need review

Urgency: HighConfidence: high
Read impact brief
Company Watch

InSphero acquires PhenoVista, expanding 3D assay and imaging services

Relevant for
QPPVSignal Management LeadLabeling LeadPV Quality Lead+3 more
Action needed

This update requires triage for Risk Management, Vendor Oversight, Inspection Readiness; confirm local obligations and document follow-up actions.

Process impact
Risk ManagementVendor OversightInspection Readiness
SOP impact

4 SOPs may need review

Urgency: HighConfidence: medium
Read impact brief

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Current context: role Labeling Lead, workflow Risk Management.