Biologics and Genetic Therapies Directorate
Health Canada's Biologics and Genetic Therapies Directorate (BGTD) is the Canadian regulatory authority of biological drugs (products made from living sources) and radiopharmaceuticals (drugs that have radioactivity) for human use in Canada.
The directorate is recognized nationally and internationally as the Canadian centre of expertise in regulating the benefits and risks of biologics and radiopharmaceuticals for human use under Canada's Food and Drugs Act and Regulations.
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What we do
Before manufacturers or sponsors can market a product under the Food and Drug Regulations in Canada, they need to obtain a Drug Identification Number (DIN) and/or a Notice of Compliance. To get these, manufacturers must provide strong evidence of the product's quality, safety, and efficacy as required under Canada's Food and Drugs Act and Regulations. We will then review the evidence and decide if the benefits of the product outweigh the risks and if the risks can be managed.
The directorate also undertakes a risk-based lot release program and regulatory research. The Lot Release Program provides an additional check on biologic drugs to help assure their safety for human use after the directorate has authorized them for the Canadian market.
We also regulate the following products to comply with specific regulations:
- Blood and blood components through the Blood Regulations (blood products are regulated under the Food and Drug Regulations)
- Cells, tissues and organs through the Safety of Human Cells, Tissues and Organs for Transplantation Regulations
- Donor semen through the Processing and Distribution of Semen for Assisted Conception Regulations
- Assisted human reproduction through the Assisted Human Reproduction Act
Once a product is authorized for marketing and sale in Canada, we work with other branches and directorates within Health Canada and the Public Health Agency of Canada to continue to monitor the product's safety and effectiveness.
Other products we regulate include:
- hemostatic agents
- bacterial and viral vaccines
- monoclonal antibodies
- allergenic extracts
- gene and cell therapies
Centres and offices
The directorate contains the following centres and supporting offices:
- Centre for Biologics Evaluation
- Centre for Evaluation of Radiopharmaceuticals and Biotherapeutics
- Office of Policy and International Collaboration
- Office of Regulatory Affairs
- Office of Quality and Information Management
- Office of Business Integration and Risk Management
The Centre for Biologics Evaluation and the Centre for Evaluation of Radiopharmaceuticals and Biotherapeutics both review drug submissions to maximize the quality, safety and efficacy of these products before their sale in Canada. This includes running laboratories that test and analyze the products. An on-site evaluation (OSE) may also be done to assess the production process at the site of manufacture. Production processes and where the product is manufactured can have a significant impact on the safety and efficacy of a biologic product.
The centres also monitor biologics by placing them on a lot release schedule that depends on the degree of risk associated with the product manufacturing, testing, and inspection history. Both centres maintain partnerships and international networks to manage and improve the safety of regulated health products.
Centre for Biologics Evaluation
The Centre for Biologics Evaluation is responsible for the regulation of vaccines for human use. It is also responsible for the regulation of biologic products manufactured from blood or other human tissues, including blood and its components for transfusion. Also housed within CBE is the only drug regulatory research group in Health Canada that supports the directorate’s regulatory programs. Central services to all BGTD laboratories are provided by the CBE Laboratory Coordination Unit.
Centre for Evaluation of Radiopharmaceuticals and Biotherapeutics
The Centre for Evaluation of Radiopharmaceuticals and Biotherapeutics regulates a wide range of biologic products, including biotechnology-derived products such as:
- monoclonal antibodies
- allergenic extracts
- gene therapies
This centre is also responsible for the regulation of radiopharmaceuticals.
Office of Policy and International Collaboration
The Office of Policy and International Collaboration develops and updates policies, standards, and guidelines that relate to biologics and radiopharmaceuticals. It works with the Policy, Planning and International Affairs Directorate’s Office of Legislative and Regulatory Modernization to develop and revise legislative and regulatory instruments for the products that we regulate. This office also:
- supports international priorities and policies in the area of biologics
- helps developing countries in regulatory capacity building
- leads regulatory and standards development cooperation with our international counterparts
Office of Regulatory Affairs
The Office of Regulatory Affairs manages submissions and applications associated with the products that the directorate regulates. It manages:
- submission screening and validation
- submission meetings with industry
- regulatory communication for the directorate
- statistical reports on submission review performance
Office of Quality and Information Management
The Office of Quality and Information Management is responsible for the directorate’s quality management system (QMS). This office is in charge of the development, maintenance, integration, measurement, analysis, and improvement of the system.
This quality management system is based on the International Organization for Standardization’s model (ISO 9001) and integrates the laboratory requirements of ISO/IEC 17025 as they apply to the lot release program.
The office is also responsible for the directorate’s information management to ensure that Health Canada and Treasury Board information management policies and best practices are applied.
Office of Business Integration and Risk Management
The Office of Business Integration and Risk Management coordinates risk management for the directorate to resolve potential issues to ensure a unified response. We also coordinate and implement the following for the directorate:
- emergency response planning
- business continuity activities
- briefing and correspondence functions
- operational planning and performance measurement
- long-term and emerging projects
- strategic initiatives
The Administrative Services Unit within this office provides administrative support and advice to all the directorate’s management and staff for:
- human resources and staffing
- purchasing of supplies and services
- budget tracking/variance reporting
- maintaining position and personnel files for directorate employees
For more information
- Drugs and Health Products
- Biologics, Radiopharmaceuticals and Genetic Therapies
- Biologics and Genetic Therapies Directorate Fact Sheets
- Applications and Submissions - Biologics, Radiopharmaceuticals and Genetic Therapies
- Biologics, radio-pharmaceuticals and genetic therapies legislation and guidelines
- Biologics and Genetic Therapies Directorate Regulatory Initiatives
- About biosimilars
Director General's Office
100 Eglantine Driveway
Address Locator 0601A
Teletypewriter: 1-800-465-7735 (Service Canada)
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