Notice of clarification to drug manufacturers and sponsors: Canadian-specific considerations in risk management plans

November 12, 2020

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Background

Canada released the Submission of Risk Management Plans and Follow-up Commitments guidance document in June 2015. This guidance outlines the requirements for submitting a Canadian RMP in the European Union (EU) format or other recognized formats, such as the U.S. Risk Evaluation and Mitigation Strategy (REMS). It also describes the requirements and process for RMP follow-up commitments and updates to Health Canada.

Purpose of notice

We are issuing this notice to help drug manufacturers and sponsors when preparing the Canadian-specific considerations and elements in the risk management plans (RMPs) for certain drug products. This notice describes what is required for certain drug products. It does not add new requirements for the submission of RMPs in Canada.

Canadian-specific considerations

Canadian-specific considerations in RMPs are outlined in section 3.8 of the guidance document. A detailed description of how the information and activities apply to Canada should be included in either:

We have provided an example of what is required under the key components to any RMP. These should be considered when submitting an RMP or follow-up commitments.

For safety issues specific to Canada

Brief summary of the Canadian epidemiology of the product's indication:

Give a description and the reason for the changes if more safety concerns need to be considered or a risk is reclassified or removed. For the Canadian context, examples include:

RMP requirement for product subtypes (referring to biosimilars and prescription opioid products):

Summary of safety concerns (important identified risks, important potential risks and missing information), which can be presented in a table format.

For pharmacovigilance activities in Canada

Routine actvities:

Additional activities:

Summary table:

For risk minimization activities and evaluation of the effectiveness of risk minimization measures in Canada

Routine activities:

Additional activities:

Summary table:

See the table below for examples of pharmacovigilance activities and risk minimization activities in Canada.

Examples of routine and additional pharmacovigilance and risk minimization activities in Canada
Activities Routine Additional
pharmacovigilance activities
  • signal detection activities
  • regulatory safety summary reports (for example, periodic safety update reports (PSURs), periodic benefit-risk evaluation reports (PBRERs))
  • post-market (post-authorization) safety studies
  • clinical trials
  • drug utilization studies
  • market research studies
  • patient registries
risk minimization activities
  • product labelling and packaging
  • drug administration training
  • educational materials for health care professionals or patients
  • restricted access program
  • restricted distribution program
  • risk communication

For inquires related to this communication, contact the Marketed Health Products Directorate.

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