Post-market Surveillance

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As the federal regulatory authority responsible for setting the standards, and monitoring the safety, efficacy and quality of all health products available for sale in Canada, Health Canada's Health Products and Food Branch (HPFB) plays a key role in helping to protect the health of all Canadians.

Minimizing risk maximizing safety

However, HPFB's role doesn't end when products are approved for sale. Equally important to protecting the health of Canadians is HPFB's work to monitor the safety, efficacy and quality of health products after they have reached the marketplace. This post-market surveillance is essential to maintaining the balance between the health benefits and risks posed by all health products. Within HPFB, post-market surveillance activities are the responsibility of the Marketed Health Products Directorate (MHPD).

MHPD works collaboratively with other HPFB directorates to perform post-market surveillance. To this end, MHPD reviews health-product safety data, conducts risk assessments and evaluates therapeutic effectiveness of marketed health products. Should a health product's safety, efficacy or quality come into question, MHPD will take appropriate action ranging from informing the public and health care community of new product safety information, to removing the product from the market.

Monitoring and tracking adverse reactions

MHPD also coordinates the Canadian Adverse Drug Reaction Monitoring Program that collects and assesses reports of adverse reactions to drugs. Drug manufacturers are required by law to inform Health Canada of any serious adverse reactions to their products. Health care professionals and consumers may also report adverse reactions. If a serious health risk is identified, MHPD will take appropriate action. This may range from distributing new product safety information to the public and/or the health care community, to removing the product from the market.

In addition, MHPD helps raise awareness about safety issues and trends by compiling and distributing a quarterly newsletter, The Canadian Adverse Reaction Newsletter, to over 100,000 stakeholders around the world.

Regulating Advertising

MHPD is also responsible for developing the regulations and guidelines that govern the advertising of marketed health products in Canada. MHPD works closely with groups such as the Pharmaceutical Advertising Advisory Board and Advertising Standards Canada to determine what information - including health claims and product safety information - may be included in advertising for health products.

Working together

HPFB believes that health care is a shared responsibility and depends on the input and collaboration of consumers, industry and health professionals both within Canada and abroad, to ensure the continued post-market safety, efficacy and quality of drugs and other marketed health products.

Health Canada
Health Products and Food Branch
250 Lanark Avenue
Graham Spry Building
Address Locator: 2005A
Ottawa ON K1A 0K9
Telephone: 613-957-1806
Facsimile: 613-954-3957
Email: hpfb-dgpsa@hc-sc.gc.ca
Web site: www.healthcanada.gc.ca/hpfb

Marketed Health Products Directorate
Tunney's Pasture
Address Locator: 0701B
Ottawa ON K1A 0K9
Telephone: 613-954-6522
Facsimile: 613-952-7738
E-mail: mhpd_dpsc@hc-sc.gc.ca
Web site: www.healthcanada.gc.ca/medeffect