On the Leading Edge of Health Science

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.

Every day the lives of Canadians are improved in countless ways by advances in the fields of biologics and genetics. These therapies have developed at an unprecedented rate in recent years and are responsible for a vast range of products and techniques that are revolutionizing health care and saving lives. Although there are undisputed benefits there can also be risks to any health science innovation. These benefits and risks are carefully monitored and managed by Health Canada.

Assessing safety, providing advice

The Biologics and Genetic Therapies Directorate (BGTD) within the Health Products and Food Branch (HPFB) of Health Canada is responsible for assessing the safety, efficacy, and quality of all biologics and genetic therapies for humans. Biologics include blood and blood products, viral and bacterial vaccines, cells, tissues, transplantation products, hormones and allergenic products, radiopharmaceuticals (pharmaceutical or biological drugs that contain a radioactive entity) and therapeutic products produced through recombinant DNA technologies.

BGTD assesses clinical trial applications and conducts laboratory tests of samples of biological drugs prior to their sale in Canada. The directorate monitors products after they are approved for use by working with other groups within HPFB, such as the Marketed Health Products Directorate. BGTD also works with the Public Health Agency Canada (PHAC) who monitors infectious disease transmission, for example through blood transfusion, and are responsible for monitoring and collecting adverse events related to vaccines. Together they provide health care professionals with the information they need to make informed recommendations to Canadians about vaccines, blood products, and other treatments. BGTD is also developing a regulatory framework and regulations related to the safety of cells, tissues and organs for transplantation.

Special access to non-marketed biologics and radiopharmaceuticals can be provided through the Therapeutic Products Directorates Special Access Programme (SAP). The SAP allows health care professionals to gain limited access to biologic and radiopharmaceutical drug products that have not yet been approved for sale in Canada.

World leader in new approaches

BGTD is pioneering new regulatory approaches in a number of areas, such as standards-based regulations now being implemented for the safety of cells, tissues, and organs. This approach is recognized as a world first, and establishes flexible rules to accommodate the rapid evolution of transplantation science, while ensuring that the safety of Canadians still remains the top priority.

All of BGTD's regulations are developed through transparent and open consultations with expert scientific advisory committees, patients, consumers, industry, individual Canadians, and other stakeholders.

Quality scientific research

BGTD is at the forefront of health-product development and maintains a dedicated research centre that promotes scientific research of the highest quality. The centre works to stay abreast of the most recent scientific advances and issues and supports credible, evidence-based decision-making.

Global developments

BGTD is involved in a number of international initiatives and works with other leading regulatory authorities to establish global standards for safety and quality. The directorate is working to help Canadians realize the full benefits of new developments in the fields of biologics and genetic therapies.

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

Biologics and Genetic Therapies Directorate
Building 7, Tunney's Pasture
Address Locator 0702E
Ottawa, ON K1A 0L2
Telephone: 613-946-7264
Facsimile: 613-946-5214
E-mail: bgtd_dgo_enquiries@hc-sc.gc.ca
Web sites: www.healthcanada.gc.ca/biologics
www.healthcanada.gc.ca/bgtd