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Risk Management Plan - Canada

Risk Management Plan

A risk management plan (RMP) should be submitted as part of the drug submission. The RMP should be designed to monitor and detect both known inherent safety concerns and potentially unknown safety signals that may result from the impurity profile and other characteristics of the biosimilar. The biosimilar sponsor should continue the assessment of unwanted immunogenicity and its clinical significance following market authorization.

The RMP should consider all identified and potential risks associated with the use of the reference biologic drug and should provide details on how these risks will be addressed in a post-market setting.

Health Canada will work with sponsors to ensure a suitable RMP is developed prior to authorization of the product. The minimum surveillance criteria for the biosimilar should be described in accordance with requirements for a new biologic drug. The RMP should include detailed information on systematic evaluation of the immunogenicity potential of the biosimilar.

The RMP should include specific (routine or additional) pharmacovigilance and risk minimisation activities similar to those in place for the reference biologic drug or justify that these activities are not relevant for the biosimilar.

A discussion about methods to distinguish adverse event reports for the biosimilar from those for other licensed products, including the reference product should be included. The RMP should be maintained and implemented throughout the life-cycle of the product.

For more information on RMPs, please refer to the Guidance Document - Submission of Risk Management Plans and Follow-up Commitments.

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:

  • a Canadian-specific RMP or
  • a Canadian addendum to the submitted RMP

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:

  • Specify any notable differences from global RMPs, including:
    • the epidemiology of the medical condition
    • risk factors for the authorized indication in Canada (for example, in cases where it is different from the authorized indication in other major jurisdictions, such as Europe and the U.S.)
    • when the drug is meant to be used by a small group of patients in Canada
  • Indicate if the safety concerns listed in the EU RMP or other recognized RMP format can be applied to Canada at the time of the submission. If not, explain why.

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:

  • genetic or external factors that are unique to the population
  • the proposed or approved indications
  • the expected use of the product, including the:
    • potential harm from an overdose
    • potential for transmission of infectious agents or medication errors
    • potential for off-label use
    • risks associated with other members of the pharmacological class
    • risks in pregnant and lactating women or in children
  • Include post-authorization experience worldwide and in Canada, if this information is applicable. See section 3.8 of the guidance document.

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:

  • routine pharmacovigilance activities (PVAs) in the Canadian context

Additional activities:

  • for each additional PVA listed in the RMP, state how it applies to Canada at the time of submission and include the milestones and timelines for reporting to Health Canada
  • where additional PVAs only apply to Canada or if international PVAs differ from those proposed for Canada, provide a description and a detailed reason for these differences
    • explain why it is important in Canada, the epidemiology of the target population and the overall risks associated with the product

Summary table:

  • summarize the additional pharmacovigilance activities in Canada in a table format

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

Routine activities:

  • provide a list of routine risk minimization activities in Canada for the safety concerns that apply to Canada at the time of submission
  • explain any differences from the submitted global RMP
  • refer to the most recent version of the Canadian product monograph, product packaging and product labelling when discussing routine risk minimization activities

Additional activities:

  • compare additional risk minimization activities proposed in Canada with those in other jurisdictions and give a reason for using a different approach, if applicable
  • describe plans to evaluate the effectiveness of risk minimization activities in Canada and include the timelines for reporting
  • make a comparison between plans to evaluate the effectiveness of risk minimization activities in Canada and measures considered and/or used in other jurisdictions, if applicable.
    • if measures proposed in Canada are different from global RMP approaches, explain the reason for these differences

Summary table:

  • summarize the additional risk minimization activities in Canada in a table format

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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