Submitting risk management plans guidance document: Overview

Date issued: February 24, 2025
Effective date: July 1, 2025
Replaces: Submission of risk management plans and follow-up commitments (June 26, 2015)

On this page

• Policy objectives
• Purpose of a risk management plan
• Scope and application
• Background
• Note about guidance documents in general

Policy objectives

Health Canada has adopted and integrated the use of risk management plans and the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) E2E guideline into the review of drugs in Canada. Amendments to the Food and Drug Regulations (FDR) to incorporate this long-standing practice into the regulations will come into force in April 2027.

From time to time, we review our guidance documents to make them clearer and reflect current practices and updated policy.

Improvements to this guidance document reflect our ongoing experience and the feedback we received from stakeholders, including during consultations on the agile licensing project. The improvements we have made since this guidance document was originally published will:

• support a lifecycle approach to drug vigilance
• enhance the quality of our regulatory assessments
• align drug vigilance with international best practices
• support timely access to safe, effective and high-quality drugs for people in Canada
• support ongoing evaluation of information that could have an impact on the benefits and risks of drug products

Purpose of a risk management plan

A risk management plan (RMP) is a document that:

• identifies and characterizes risks and uncertainties of a drug, such as:
  • important identified risks
  • important potential risks
  • missing information
• describes pharmacovigilance measures designed to monitor and address risks and uncertainties
• describes risk minimization measures, such as interventions designed to prevent or reduce risks
• describes methods to assess the effectiveness of those risk minimization measures and interventions

Health Canada may request RMPs for drugs when:

• there is a significant degree of uncertainty about the risks associated with the drug
• the drug presents a serious risk of injury to human health that warrants measures, other than labelling, to reduce the probability or severity of such an injury

The RMP may be used:

• to identify and characterize the risks associated with the drug and to prevent or reduce those risks or address uncertainties
• by the Minister to assess the safety and effectiveness of the drug
• as a factor in our decision to issue, suspend or remove a market authorization

For specific examples, refer to When to file a risk management plan with Health Canada.

Scope and application

This guidance document is for sponsors and market authorization holders (MAHs). It explains when and how to submit an RMP and RMP updates over the course of the lifecycle of a drug.

It also clarifies:

• what constitutes an acceptable RMP
• how to address the Canadian context, including the format for a Canadian-specific addendum
• the submission of RMP summaries, including the standard for an acceptable RMP summary format
• how to manage the submission of RMPs

The principles and practices outlined in this guidance document apply to drugs for human use (defined in section 2 of the Food and Drugs Act (FDA)) regulated under the FDR.

These include the following products that are within the scope of the ICH E2E guideline:

• pharmaceutical drugs, such as prescription and non-prescription drugs, including generic drugs
• biologic drugs as set out in Schedule D to the FDA, including:
  • vaccines
  • fractionated blood products
  • biotherapeutic drugs, including biosimilars
• radiopharmaceutical drugs as set out in Schedule C to the FDA

This document does not apply to the following products:

• veterinary drugs
• natural health products
• whole blood and blood components
• medical devices, except when they are part of a combination product submission and classified in 1 of the applicable product categories

Sponsors and MAHs should be familiar with the requirements of the FDA and the regulations for routine pharmacovigilance measures, such as these requirements from the FDR:

• adverse reaction reporting (C.01.017)
• preparing annual summary reports (C.01.018)
• providing information on serious risk of injury to human health (C.01.050)

The need for an RMP is determined on a product-by-product basis, taking into account the available information about risks and uncertainties.

Where applicable, the processes for reviewing RMPs will be compatible with and complement other regulatory activities, such as the review of market authorization submissions.

Background

We base a decision to authorize a drug for sale in Canada on evidence of its safety, efficacy and quality. The benefits of the drug must outweigh the risks within the conditions of use specified in the product labelling.

Authorization is based on the information available at the time. Information about the safety profile of the drug can change over time as more patients with varying characteristics are given the drug. For example, during the early post-marketing period, the drug might be used:

• in settings different from those studied in clinical trials
• by a much larger population in a relatively short timeframe

As an observer country at the time, Canada was a signatory to the ICH E2E Pharmacovigilance planning guideline, which was published in 2004. This guideline gives instruction in cases where there are important identified risks of a drug, important potential risks and important missing information. This includes potentially at-risk populations and situations where the product is likely to be used that have not been studied pre-approval.

Since the release of the E2E guideline, the European Medicines Agency (EMA) and other regulators have released their own guidelines to reflect the intent of the ICH guideline. They have updated them from time to time. Many sponsors/MAHs refer to these guidelines as their preferred approach.

In February 2009, Health Canada published a notice on the implementation of risk management planning. The notice gave advice on:

• key components
• acceptable formats
• submission process
• reasons, criteria and scope for RMP requests

In June 2015, we published a guidance document on the Submission of risk management plans and follow-up commitments. This document provided sponsors/MAHs with guidance on how to proceed when submitting an RMP.

In August 2020, we published a notice of clarification specifying that RMPs are not meant to restrict access to Canadian reference products. In November 2020, we published a second notice of clarification on including Canadian-specific considerations in RMPs.

Note about guidance documents in general

Guidance documents provide assistance to industry and health care professionals on how to comply with governing statutes and regulations. They also provide guidance to Health Canada staff on how mandates and objectives should be met fairly, consistently and effectively.

Guidance documents are administrative, not legal, instruments. This means that flexibility can be applied. However, to be acceptable, alternate approaches to the principles and practices described in this document must be supported by adequate justification. They should be discussed in advance with the relevant program area to avoid the possible finding that applicable statutory or regulatory requirements have not been met.

As always, Health Canada reserves the right to request information or material, or define conditions not specifically described in this document, to help us adequately assess the safety, efficacy or quality of a therapeutic product. We are committed to ensuring that such requests are justifiable and that decisions are clearly documented.

This document should be read along with the relevant sections of the regulations and other applicable guidance documents.

Sponsors/MAHs should refer to the most up-to-date versions of the guidance documents. The guidance documents are a starting point only to help sponsors/MAHs.