Marketed Health Products Directorate

Health Canada's Marketed Health Products Directorate monitors and assesses the safety and effectiveness of authorized health products that come onto the market in Canada. We take regulatory action when safety issues are identified. We also communicate openly and transparently about those risks to help the public make informed decisions.

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What we do

The Marketed Health Products Directorate is part of the Health Products and Food Branch of Health Canada. The Directorate regulates human health products. We do this in a number of ways. We work with other organizations to assess the benefits and risks of marketed health products. We communicate those risks to health care professionals and the public. And, we oversee the regulatory requirements for advertising health products.

The Directorate is made up of 4 bureaus and 2 offices. Employees who work in the Directorate are from a variety of backgrounds, such as medicine, biology, microbiology, pharmacology, epidemiology, policy, finance and administration.

How we do it

The Directorate is composed of the following areas:

Director General's Office

The Director General's Office:

  • provides overall leadership to ensure the Directorate fulfills its mandate
  • oversees and directs projects identified in the Directorate's strategic vision and that advance the priorities set by the branch, department and federal government
  • communicates with stakeholders in Canada and around the world
  • reports the Directorate's work to senior officials in Health Canada

Marketed Pharmaceuticals Bureau

The Marketed Pharmaceuticals Bureau conducts post-market surveillance of marketed prescription drugs to determine the safety profile of these products. For example, we:

  • conduct safety assessments and benefit-risk assessments
  • review adverse event reports and risk management plans
  • monitor and analyze marketed prescription pharmaceutical safety data

Based on these safety reviews, we develop recommendations and strategies to manage and reduce the risk(s). For example, we may:

  • communicate the risks to the public and health care professionals
  • update the labelling information
    • to add information about a risk or to limit use in patients with some risk factors
  • ask manufacturers to conduct more studies to monitor potential risks
  • remove the product from the market

Office of Policy, Risk Advisory and Advertising

The Office of Policy, Risk Advisory and Advertising contributes to an effective regulatory framework for monitoring health products in Canada. For example, we:

  • develop policies and guidance
  • coordinate transparency initiatives
  • write risk communications and summary safety reviews
  • write and publish monthly editions of Health Product InfoWatch
  • lead the prevention and management of medication incidents involving a health product's name, label, and packaging
  • oversee health product regulatory advertising of licensed health products to ensure that ads are not false, misleading or deceptive

In addition, our MedEffect program was developed to make it easy for health professionals and consumers to:

  • access up-to-date information on the safety of health products
  • report an adverse reaction or side effect to a specific health product

Health Products Surveillance and Epidemiology Bureau

The Health Products Surveillance and Epidemiology Bureau is responsible for post-market surveillance. We use the results from these monitoring activities to assess the safety and effectiveness of health products and to inform regulatory actions.

This work involves:

  • collecting and analyzing data from adverse reaction and medical device incident reports
  • critically appraising observational studies and scientific protocols and developing methodologies to assess real world evidence
  • providing expert advice to identify safety and effectiveness issues that may not have been apparent during clinical trials
    • issues may arise only after a drug has been approved and marketed
    • regulatory decisions take into account this expert advice
  • communicating with and educating stakeholders on the need to share information regularly

Domestic and international collaboration, sound data stewardship, a rigorous quality assurance framework and a range of transparency initiatives help to support this work.

Bureau of Biologics, Radiopharmaceuticals and Self-Care Products

The Bureau of Biologics, Radiopharmaceuticals and Self-Care Products conducts post-market surveillance of biologics, radiopharmaceuticals, self-care products and non-prescription drugs to determine the safety profile of these products:

  • radiopharmaceuticals
  • natural health products
  • vaccines, including COVID-19 vaccines
  • cells, tissues and organs for transplantation
  • sperm and ova for assisted human reproduction
  • cell and gene therapy and biotechnology products
  • biologics products, including COVID-19 treatments
  • blood, blood components for transfusions and blood products

For example, we:

  • conduct safety assessments and benefit-risk assessments
  • review adverse event reports and risk management plans
  • monitor and analyze marketed prescription pharmaceutical safety data

Based on these safety reviews, we develop risk management strategies to mitigate the identified risks. For example, we:

  • update the labelling information
    • to add information about a risk or to limit use in patients with some risk factors
  • communicate the risks to the public and health care professionals
  • ask manufacturers to conduct more studies to monitor potential risks
  • recommend on occasion the removal of a product(s) from the market

Bureau of Strategic Engagement and Integrated Management Services

The Bureau of Strategic Engagement and Integrated Management Services carries out the following services:

  • strategic HR
  • resource management
  • stakeholder engagement
  • regulatory project management
  • outreach and publishing activities
  • strategic planning, business planning, measurement and reporting

Contact us

Marketed Health Products Directorate
Health Products and Food Branch
Health Canada
Address Locator 1912C
Ottawa ON  K1A 0K9
Email: mhpd-dpsc@hc-sc.gc.ca
Telephone: 613-954-6522
Teletypewriter: 1-800-465-7735 (Service Canada)

To contact Directorate staff in the regions, visit:

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