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 communicate openly and transparently about those risks to help the public make informed decisions. We also assign Drug Identification Numbers (DIN), and administer drug-related intellectual property regimes.
On this page
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
- Marketed Pharmaceuticals Bureau
- Office of Policy, Risk Advisory, and Advertising
- Office of Submissions and Intellectual Property
- Health Products Surveillance and Epidemiology Bureau
- Bureau of Biologics, Radiopharmaceuticals and Self-Care Products
- Bureau of Strategic Engagement and Integrated Management Services
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:
- stakeholder engagement
- 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
Office of Submissions and Intellectual Property
The Office of Submissions and Intellectual Property provides support to various directorates within the Branch in areas including:
- Publishing activities
- Assignment of Drug Identification Numbers (DIN)
- Processing and cost recovery of human drug submissions and drug master files
- Administration of drug related intellectual property regimes, including the Patented Medicines (Notice of Compliance) Regulations, the Certificate of Supplementary Protection Regulations under the Patent Act, and the Data protection provisions under the Food and Drug Regulations
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
- reports come from health care professionals, health institutions, consumers/patients, market authorization holders, manufacturers and importers (domestic and foreign)
- both the Canada Vigilance Program and the Canadian Medical Devices Sentinel Network (CMDSNet) collect 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
- regulatory project management
- 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:
Office of Submissions and Intellectual Property
General inquiries
Office of Submissions and Intellectual Property
Address Locator: 1908A
8th Floor – Room 811A Jeanne Mance Building
200 Eglantine Driveway
Ottawa ON K1A 0K9
E-mail: osip-bppi@hc-sc.gc.ca
Teletypewriter: 1-800-465-7735 (Service Canada)
Cost Recovery (for human drug submissions)
E-mail: cost.recovery@hc-sc.gc.ca
Drug Identification Number Unit
E-mail: din@hc-sc.gc.ca
Master File Administration Unit
E-mail: dmf.enquiries-fmm@hc-sc.gc.ca
Office of Patented Medicines and Liaison
E-mail: opml-bmbl@hc-sc.gc.ca
Related links
- Recalls and safety alerts
- Drugs and health products
- Drug and medical device databases
- Keeping health products in Canada safe
- Medical device incidents online database
- Mandatory medical device problem reporting
- Canada vigilance adverse reaction online database
- Adverse reaction and medical device problem reporting