Safe, Effective, High Quality Pharmaceuticals

Help on accessing alternative formats, such as Portable Document Format (PDF), Microsoft Word and PowerPoint (PPT) files, can be obtained in the alternate format help section.

---

From non-prescription health products such as acetaminophen to highly potent drugs prescribed for cancer therapy, pharmaceuticals play an important role in Canadians' health and in Canada's health care system. They can save lives, prevent the spread of disease, improve our quality of life, and control pain and suffering. Health Canada believes the role of pharmaceuticals is likely to grow in the future as technological advances result in drugs that offer new treatment options.

The Health Products and Food Branch (HPFB) of Health Canada is the federal authority that regulates all pharmaceuticals meant for human use in Canada.

Pharmaceuticals: prescription and non-prescription drugs

Pharmaceuticals are mostly synthetic products made from chemicals for therapeutic use. HPFB's Therapeutic Products Directorate (TPD) is responsible for the regulation and evaluation of prescription and non-prescription pharmaceuticals in Canada.

All pharmaceuticals for use by humans in Canada are subject to the Food and Drugs Act and its regulations.

Minimizing risk, maximizing safety

New pharmaceuticals are carefully reviewed by TPD before being authorized for sale in Canada. Pharmaceutical manufacturers must submit substantive scientific evidence of a product's safety, efficacy, and quality. HPFB scientists review this evidence to determine whether the potential risks from the new pharmaceuticals are acceptable when balanced against the positive effects.

HPFB's Special Access Programme (SAP) allows health care professionals to gain limited access to pharmaceutical products that have not yet been approved for sale in Canada. Special access can be requested for emergency use or if conventional therapies have failed, are unavailable or are unsuitable to treat a patient. SAP can also respond to specific health crises, such as an outbreak of a communicable disease.

Post-Market Surveillance

TPD's commitment to public safety continues after a pharmaceutical is introduced into the health care system. TPD works closely with the HPFB Inspectorate and Marketed Health Products Directorate to monitor approved pharmaceuticals for compliance with manufacturing regulations and guidelines, advertising regulations and expected and unexpected health risks such as adverse reactions.

TPD also works with other partners and stakeholders to monitor the on-going benefits and risks of approved pharmaceuticals. These include other groups within Health Canada, scientific advisory committees, independent experts, patient and consumer groups, health professionals, other regulatory agencies, professional associations, and other levels of government.

Meeting global standards

Concern for human health transcends borders. Health Canada is recognized around the world for its product safety standards and risk management approach. HPFB participates in international regulatory cooperation work, sharing resources and knowledge with other governments around the world. TPD is a significant contributor to international harmonization efforts, especially through the creation and implementation of technical guidance and standards for the development, registration and control of pharmaceuticals.

Working smarter

Recent advances in technology and health research are contributing to an unprecedented increase in the number of new pharmaceuticals. Health Canada is working to streamline and improve its regulatory framework with the goal of giving Canadians faster access to more new pharmaceuticals while continuing to focus on public safety.

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

Therapeutic Products Directorate
Building 2, Tunney's Pasture
Address Locator: 0201A1
Ottawa, ON K1A 1B9
Phone: (613) 941-0827
Fax: (613) 941-0825
Email: SIPDMail@hc-sc.gc.ca
Website: www.healthcanada.gc.ca/drugproducts