What changed
Health Canada replaced its 26 June 2015 RMP submission guidance with a new overview guidance issued 24 February 2025 and effective 1 July 2025. In parallel, Health Canada linked the guidance to Agile Licensing-related Food and Drug Regulations provisions on RMPs that will come into force on 1 April 2027 and referenced transitional provisions for RMPs submitted before those regulations take effect.
Why it matters
RMPs are core pharmacovigilance risk management deliverables used in Health Canada’s review of drugs in Canada and are explicitly framed as aligned with ICH E2E in the updated overview. Any change to national submission guidance (including summary and form expectations) can affect dossier completeness, Health Canada review interactions, and governance over risk management content that connects to PV planning and risk minimization measures. The stated effective date (1 July 2025) and the separately stated regulatory in-force date (1 April 2027) create two compliance milestones that PV/RA organizations should manage, including how existing RMPs are handled under referenced transitional provisions.
Practical implication
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from the overview (e.g., RMP note to reviewer, Canadian-specific addendum, RMP summary template) and map deltas vs the superseded 2015 approach. 2) Update Canada submission checklists/work instructions for the 1 July 2025 effective date, including the requirement that the RMP include a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.