Clarification on Canadian considerations in risk management plans
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Clarification on Canadian considerations in risk management plans The government of Canada has issued a notice of clarification for drug manufacturers and sponsors preparing Canadian-specific considerations in risk management plans (RMPs) for certain drug products. It elaborates on the Submission of Risk Management Plans and Follow-up Commitments guidance document released in Canada in 2015, which outlines requirements for submitting a Canadian RMP, and describes the requirements and process for RMP follow-up commitments and updates to Health Canada. A Canadian RMP should specify any notable differences from global RMPs in the epidemiology of the medical condition, risk factors for the authorised indication in Canada, and when the drug is intended for use in a small patient population in Canada. It should indicate if safety concerns listed in an EU RMP or other recognised RMP can be applied to Canada, or explain why not. It should describe reasons for the addition or removal of safety concerns, such as genetic or external factors unique to a population and proposed or approved indications, including: potential harm from overdose, transmission of infectious agents or medication errors, or off-label use; and risks associated with the drug class or during pregnancy and lactation and in children. Post-authorisation experience in Canada and globally should be included, if applicable. Canadian-specific RMP requirements are also described for biosimilars and prescription opioids. Routine pharmacovigilance activities (PVAs) and additional PVAs should be listed in the RMP; each additional PVA should state how it applies in Canada and timelines for reporting to Health Canada; reasons should be given if PVAs for a product differ from international PVAs, and additional PVAs should be tabulated. Routine risk minimisation activities should also be listed in the RMP and refer to the most recent Canadian product monograph, product packaging and product labelling. Additional risk minimisation activities should also be compared with those in other jurisdictions. Government of Canada. Notice of clarification to drug manufacturers and sponsors: Canadian-specific considerations in risk management plans. Internet Document : 12 Nov 2020. Available from: URL: https://www.canada.ca/en/health-canada/services/drugs-health-products/reports-publications/medeffect-canada/profile-guidance-document803518257 submission-risk-management-plans-follow-commitments/notice-clarification-drug-manufacturers-sponsors.html
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Reactions 28 Nov 2020 No. 1832
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