Health Canada's Biologics and Genetic Therapies Directorate (BGTD) is the Canadian federal authority that regulates biological drugs (products derived from living sources) and radiopharmaceuticals for human use in Canada, whether manufactured in Canada or elsewhere. Some of the products regulated by BGTD include: blood and blood products, hemostatic agents, bacterial and viral vaccines, hormones, enzymes, cytokines, monoclonal antibodies, allergenic extracts, gene and cell therapies, tissues, and organs. The BGTD also oversees the activities of the blood establishments.
Before manufacturers or sponsors are eligible to market a product in Canada, they must obtain a Drug Identification Number (DIN) and / or a Notice of Compliance, as applicable. In order to do so, manufacturers must provide sound evidence of the product's quality, safety and efficacy as required under Canada's Food and Drugs Act and Regulations such that, upon conclusion of the review, the BGTD can determine that the benefits of the product outweigh its risks and the risks can be mitigated. In the case of blood components, establishments that perform licensable activities in Canada (fabricating, packaging/labeling, testing, distributing, importing or wholesaling) must provide sufficient evidence on the safety of the drug and obtain an Establishment License. There is no pre-market authorization process for human cells, tissues and organs for transplantation, however, establishments involved in their processing and distribution must register with Health Canada and adhere to strict safety requirements. Once a product is authorized for marketing in Canada, the BGTD, in concert with other partners, namely the Health Products and Food Branch Inspectorate (HPFBI), the Marketed Health Products Directorate (MHPD) and the Public Health Agency of Canada (PHAC) monitor the product's safety and effectiveness throughout the lifecycle of the product in Canada. The BGTD also undertakes a risk based lot release program as well as regulatory research.
The BGTD's work provides health care professionals with the information they need to make informed recommendations to Canadians about biological and radiopharmaceutical products, and provides the information patients need to make informed decisions.
BGTD is recognized nationally and internationally as the Canadian centre of expertise in regulating the benefits and risks of biologics and radiopharmaceuticals for human use. BGTD accomplishes its vision by:
BGTD works to maximize the quality, safety and efficacy of biological and radiopharmaceutical products in Canada.
BGTD achieves this mission through a program approach in collaboration with organizations such as the Marketed Health Products Directorate, the Health Products and Food Branch Inspectorate, the Therapeutic Products Directorate, and the Public Health Agency of Canada. This program approach facilitates the life cycle management of the quality, safety and effectiveness of products before and after their introduction to the Canadian market. It allows the organizations within the program to conduct pre-market reviews, monitor and deal with biologic and radiopharmaceutical adverse events, maintain post approval surveillance, carry out compliance and enforcement activities, and conduct product recalls in an efficient, expeditious manner.
BGTD's regulatory framework enables the authorization of safe, effective and quality products, as well as provides for the timely and transparent dissemination of information to Canadians concerning the risks and benefits of these products. These activities are carried out in cooperation with stakeholders.
The BGTD is organized into three Centres and six Offices/Unit: