Canada tells drug sponsors how to submit risk management plans in EU/US formats
This article was originally published in SRA
Health Canada has issued final guidance explaining the steps that drug sponsors should follow when submitting a Canadian risk management plan in the European or other recognized formats1. The guidance also explains how sponsors should follow-up on RMP commitments and submit updates on this front.
The guideline is intended to help implement Health Canada's adoption of the international guidance on pharmacovigilance planning (ICH E2E). The latest guideline defines Health Canada's expectations for RMP follow-up commitments; provides sponsors with an overview of review and approval timelines (including deadlines for responding to questions); and explains how the Therapeutic Products Directorate (TPD), the Biologics and Genetic Therapies Directorate (BGTD), the Natural and Non-prescription Health Products Directorate (NNHPD) and the Marketed Health Products Directorate (MHPD) manage the submission of RMPs and follow-up commitments.
Health Canada adopted the ICH E2E guideline in February 2009, at which time it said that the EU format on RMPs would be acceptable for fulfilling Canadian requirements for RMPs. It also clarified that other recognized formats (eg, the US risk evaluation and mitigation strategies or REMS) could be used provided that they included all the essential elements of the EU RMP (ie, safety specification section, pharmacovigilance activities, risk minimization activities, and evaluating effectiveness of risk minimization measures).
Health Canada added, however, that if there were special considerations related to medical practice or populations in Canada, the sponsor/ market authorization holder should also provide a Canadian context to the submitted RMP. The latest guideline includes examples of special considerations related to medical practice or populations in Canada that should be considered, if applicable, when submitting an RMP or follow-up commitments. The guideline clarifies that Canadian-specific sections can be provided in the form of a Canadian-specific RMP or in an addendum to an already prepared EU RMP or RMP in other recognized formats.
Among other things, the guideline explains: when sponsors should file an RMP; how to make use of foreign reviews, if available; the details that sponsors should include in their RMP "cover letter" and "note to reviewer"; how to update an RMP and examples of situations where an RMP update would normally be expected; the processes followed at Health Canada for reviewing an RMP and follow-up commitments; and how sponsors can make a request for a status update of their RMP submission under review.
References
1. Guidance Document - Submission of Risk Management Plans and Follow-up Commitments, 26 June 2015, www.hc-sc.gc.ca/dhp-mps/pubs/medeff/_guide/2015-risk-risques_management-gestion_plans/index-eng.php