Biologic and Radiopharmaceutical Drugs Directorate
Health Canada's Biologic and Radiopharmaceutical Drugs Directorate (BRDD) regulates biological drugs (products made from living sources, including vaccines), radiopharmaceuticals (drugs that have radioactivity), and cells, tissues and organs for human use in Canada. The Directorate is also the regulatory authority responsible for the Assisted Human Reproduction (AHR) Act and its supporting regulations.
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The Biologic and Radiopharmaceutical Drugs Directorate (BRDD) provides high quality and timely risk-based decisions using currently available scientific and clinical evidence, enabling access to safe, effective, and quality biologics and radiopharmaceuticals for the people of Canada.
We accomplish this in a predictable, transparent, and open manner using a Quality Management System (QMS) which is based on requirements of applicable statutes, regulations, policies and guidelines, including the ISO 9001 and ISO 17025 Standards.
With senior management support, BRDD is fully committed to continual advancement of the effectiveness of the QMS through improvement of processes and services of the organisation.
What we do
Before manufacturers can market a product in Canada, under the Food and Drug Regulations , 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. BRDD assesses the submission and reviews the clinical and quality information, as required, to determine whether the benefits of the product outweigh the risks, and if or how the risks can be managed. BRDD also regulates clinical trials conducted in Canada to achieve high standards of excellence in research and development and to protect clinical trial subjects.
To determine if a drug meets Health Canada’s requirements for market authorization, clinical reviews are conducted based on results of pre-clinical and clinical studies whose objective is to determine whether the drug delivers its claimed benefit with minimal side effects.
The chemistry and manufacturing information about the drug is also reviewed to ensure the drug meets quality standards. Since biologic drugs originate from living organisms or cells, the manufacturing of drugs of this type is typically more complex. As such, the quality review of a biologic can include on-site evaluations and in-house laboratory assessments such as lot release testing.
BRDD also regulates the following products to comply with specific regulations:
- Blood and blood components through the Blood Regulations
- Cells, tissues and organs through the Safety of Human Cells, Tissues and Organs for Transplantation Regulations
- Assisted human reproduction through the Assisted Human Reproduction Act and its supporting regulations
Once a product is authorized for sale in Canada, BRDD works 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.
Centres and offices
The directorate contains the following centres and supporting offices:
- Centre for Biologics Evaluation
- Centre for Evaluation of Radiopharmaceuticals and Biotherapeutics
- Centre for Regulatory Excellence, Statistics and Trials
- Office of Policy and International Collaboration
- Office of Quality and Information Management
- Office of Business Integration
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.
Centre for Biologics Evaluation
The Centre for Biologics Evaluation (CBE) is responsible for the regulatory and scientific evaluation of vaccines, allergenic extracts, albumins, immunoglobulins, coagulation factors and their inhibitors from human plasma or from biotechnology, heparins and heparinoids, blood and blood components, cells and cell based medicines, gene therapies, tissues and organs for transplantation, and sperm and ova for use in assisted human reproduction. Specifically, it evaluates the quality (chemistry and manufacturing) data for these products, both in support of market authorizations and clinical trials, and delivers an ISO accredited lot release program. CBE also supports the directorate's regulatory research programs by conducting scientific research to address knowledge gaps and build scientific expertise.
Centre for Evaluation of Radiopharmaceuticals and Biotherapeutics
The Centre for Evaluation of Radiopharmaceuticals and Biotherapeutics (CERB) is responsible for the regulatory and scientific evaluation of radiopharmaceutical drugs and a wide range of biologic products. This includes biotechnology-derived products such as monoclonal antibodies, cytokines, hormones and enzymes, that are made by manipulating living organisms. CERB evaluates the quality data (chemistry and manufacturing) and clinical data for these products at the pre-market application stages, and quality data for clinical trials involving them. Further, for vaccines and blood and blood products, it evaluates the clinical data for these products.
Centre for Regulatory Excellence, Statistics and Trials
The Centre for Regulatory Excellence, Statistics and Trials (CREST) is responsible for support of submission management and interactions with drug sponsors and international regulatory partners, oversight of clinical trials to ensure participant protection and biostatistical analysis in support of the review of drug submissions. CREST leads initiatives aimed at coordinating regulatory intelligence and risk management activities, and at supporting access to medicines for specific populations, such as paediatrics.
Office of Policy and International Collaboration
The Office of Policy and International Collaboration (OPIC) develops policies, standards, guidance, and directives related to: biologic and radiopharmaceutical drugs; cells, tissues and organs; and assisted human reproduction. The Office conducts stakeholder consultations and coordinates international collaboration.
Office of Quality and Information Management
The Office of Quality and Information Management (OQIM) is responsible for the directorate's quality management system (QMS). BRDD’s QMS is certified by ISO 9001 registrar and accredited by the ISO 17025 accreditation body.
Office of Business Integration
The Office of Business Integration (OBI) provides horizontal organizational support to BRDD. Further, it manages the Bilateral Meeting Program (BMP) with stakeholders.
For more information
- Drugs and Health Products
- Biologic and Radiopharmaceutical Drugs Directorate Fact Sheets
- Applications and Submissions - Biologics, Radiopharmaceuticals
- Biologics, radio pharmaceuticals and genetic therapies legislation and guidelines
- Biologic and Radiopharmaceutical Drugs Directorate Regulatory Initiatives
- About biosimilars
Building 6, Address Locator: 0601B
100 Eglantine Driveway
Teletypewriter: 1-800-465-7735 (Service Canada)
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