Marketed Health Products Directorate

Health Canada’s Marketed Health Products Directorate is an evidence-based program that works collaboratively with other organizations to assess health product risks and make regulatory decisions to manage those risks. Once these risks are assessed they are communicated openly and transparently to help Canadians make informed decisions.

The Directorate also leads the development of regulations for reporting adverse reactions and works closely with international organizations in the harmonization of regulatory systems to facilitate the sharing of information.

On this page:

What we do

The Marketed Health Products Directorate regulates human health products by:

  • collecting, monitoring and analyzing adverse reaction, medical device and medication incident data
  • conducting benefit-risk assessments of marketed health products
  • communicating product-related risks to health care professionals and the public
  • overseeing the advertising regulatory requirements of health products
  • providing policies to effectively regulate marketed health products

Offices and bureaus

The Directorate is composed of the following areas:

Director General's Office

The Director General's Office plays a key coordination and strategic leadership role across the Directorate. We liaise with other directorates and link with committees and management at both the branch and department levels.

Bureau of Strategic Initiatives and Planning

The Bureau of Strategic Initiatives and Planning provides strategic advice, support, and oversight of all Directorate resource management functions including:

  • finance
  • human resources
  • contracting/procurement
  • facilities management/accommodations
  • business continuity

We provide leadership in the development of strategic operational planning, performance management, and a broad range of planning, reporting, and business case tools.  We also are responsible for the coordination and support of the Directorate’s outreach and publishing activities.

Marketed Biologicals, Biotechnology and Natural Health Products Bureau

The Marketed Biologicals, Biotechnology and Natural Health Products Bureau conducts post-market surveillance of:

  • vaccines
  • blood and blood products
  • cells, tissues and organs
  • biotechnology products
  • biologicals
  • natural health products
  • non-prescription drugs

Through clinical and scientific evaluation, we review and analyse safety data for marketed biologics, natural health products and non-prescription pharmaceuticals (including conducting safety assessments, and benefit-risk assessments, and reviewing adverse event reports and Risk Management Plans) in order to determine the safety profile of these products. Based on these safety reviews we develop risk management strategies to mitigate the identified risks when needed. Some risk management strategies include:

  • communicating the risks to Canadians and health care professionals
  • updating the labelling information to, for example, add information about a risk or to limit use in patients with some risk factors
  • asking manufacturers to conduct additional studies to monitor potential risks
  • and occasionally removing products from the market

Marketed Health Products Safety and Effectiveness Information Bureau

The Marketed Health Products Safety and Effectiveness Information Bureau collects, assesses, and disseminates adverse event information for health products marketed in Canada. This includes suspected adverse reaction reports for marketed health products such as pharmaceuticals, natural health products and biologics, as well as reports of incidents involving medical devices, which are submitted by health care professionals, consumers/patients, market authorization holders and importers, both domestic and foreign. Our work is supported by international collaboration, sound data stewardship, a rigorous quality assurance framework and diverse transparency initiatives.

Marketed Pharmaceuticals and Medical Devices Bureau

The Marketed Pharmaceuticals and Medical Devices Bureau conducts post-market surveillance of:

  • marketed prescription drugs
  • medical devices

Through clinical and scientific evaluation, we review and analyse marketed prescription pharmaceuticals and medical devices safety data (including conducting safety assessments, and benefit-risk assessments, and reviewing adverse event reports and Risk Management Plans) in order to determine the safety profile of these products. Based on these safety reviews we develop risk management strategies to mitigate the identified risks when needed. Some risk management strategies include:

  • communicating the risks to Canadians and health care professionals
  • updating the labelling information to, for example, add information about a risk or to limit use in patients with some risk factors
  • asking manufacturers to conduct additional studies to monitor potential risks
  • and occasionally removing products from the market

Office of Pharmacoepidemiology and Data Analytics

The Office of Pharmacoepidemiology and Data Analytics (OPEDA) provides epidemiological and bio-statistical expertise in the assessment of post market health product safety and effectiveness:

  • to ensure best practices in the use of real world evidence to inform regulatory decision-making;
  • to analyze pharmaceutical sales and other health-care data to describe and characterize drug utilization levels and treatment patterns;
  • to develop and apply analytics techniques for previously untapped data sources to gain new insights resulting in better and faster decisions;

Therapeutic Effectiveness and Policy Bureau

The Therapeutic Effectiveness and Policy Bureau provides policy advice and regulatory coordination capacity in order to contribute to an effective regulatory framework for product vigilance in Canada. This includes the following activities:

  • developing policies and guidance
  • writing risk communications and summary safety reviews
  • coordinating transparency initiatives
  • writing and publishing monthly editions of Health Product InfoWatch
  • contributing to international cooperation
  • overseeing the Department’s health product regulatory advertising activities, to ensure that health product advertisements are not false, misleading or deceptive.
  • leading the prevention and management of medication incidents involving a health product’s name, label, and packaging, and providing expert advice on health product name submissions.

For more information

Contact us

Marketed Health Products Directorate
Health Products and Food Branch
Health Canada
Address Locator 1912C
Ottawa, Ontario
K1A 0K9

E-mail: mhpd_dpsc@hc-sc.gc.ca
Telephone: 613-954-6522
Facsimile: 613-952-7738
Teletypewriter: 1-800-465-7735 (Service Canada)


Bureau of Strategic Initiatives and Planning
E-mail: mhpd_dpsc@hc-sc.gc.ca
Telephone: 613-946-0833
Facsimile: 613-960-8229


Marketed Biologicals, Biotechnology and Natural Health Products Bureau

E-mail: mhpd_dpsc@hc-sc.gc.ca
Telephone: 613-948-6011
Facsimile: 613-954-2354

Marketed Health Products Safety and Effectiveness Information Bureau
E-mail: mhpd_dpsc@hc-sc.gc.ca
Telephone: 613-957-0650 
Facsimile: 613-957-0335

Marketed Pharmaceuticals and Medical Devices Bureau
E-mail: mhpd_dpsc@hc-sc.gc.ca
Telephone: 613-946-5140
Facsimile: 613-952-6011

Office of Pharmacoepidemiology and Data Analytics 
E-mail: mhpd_dpsc@hc-sc.gc.ca
Telephone: 613-941-4408
Facsimile: 613-952-7738

Therapeutic Effectiveness and Policy Bureau
E-mail: mhpd_dpsc@hc-sc.gc.ca
Telephone: 613-954-6779
Facsimile: 613-948-7996

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