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.
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 Oncology, Radiopharmaceuticals and Research
- Centre for Blood, Blood Products and Biotherapeutics
- Centre for Vaccines, Clinical Trials and Biostatistics
- Centre for Policy, Pediatrics, and International Collaboration
- Office of Quality and Information Management
- Office of Business Integration
- Office of Regulatory Affairs
Centre for Oncology, Radiopharmaceuticals and Research
The Centre for Oncology, Radiopharmaceuticals and Research (CORR) is responsible for the regulatory and scientific evaluation of the quality parameters (chemistry and manufacturing) and clinical data for oncology products, radiopharmaceuticals and gene therapies at the pre-market application stages. It also evaluates cells and cell-based medicines, tissues and organs for transplantation as well as sperm and ova for use in assisted human reproduction. In addition, the CORR conducts regulatory-based scientific research, supporting BRDD in areas that include vaccines, stem cells, nanomedicines, glycobiology, cellular immunology, gene therapies, antimicrobial resistance, as well as protein structure and analytical biotechnologies. The CORR supports common services to BRDD laboratories.
Centre for Blood, Blood Products and Biotherapeutics
The Centre for Blood, Blood Products and Biotherapeutics (CBBB) is responsible for the regulatory and scientific evaluation of a wide range of biologic products in the domain of neurological, auto-immune, allergy, metabolic and endocrine diseases, for quality, clinical safety and efficacy. Product lines include blood components, blood products, heparins and their derivatives, and biotechnology-derived products made by manipulating living organisms, such as monoclonal antibodies, cytokines, hormones, enzymes and coagulation factors and inhibitors. The centre also evaluates the quality component of these products when used in clinical trials. Lastly, the centre is responsible for horizontal initiatives aimed at coordinating regulatory intelligence, risk management activities as well as secretariat functions for HPFB for international work sharing (Access Consortium work sharing initiatives) and parallel reviews (US FDA's Project Orbis).
Centre for Vaccines, Clinical Trials and Biostatistics
The Centre for Vaccines, Clinical Trials and Biostatistics (CVCTB) is responsible for the regulatory and scientific evaluation of clinical trials to ensure participant protection, quality (chemistry and manufacturing) evaluation of vaccines and allergenic extracts as well as clinical evaluation of preventative vaccines, infectious disease therapeutics, anti-infective hyper-immune globulins and changes to clinical processes used by establishments in collecting blood and plasma. It also provides biostatistical expertise to support the review of drug submissions for the Directorate.
Centre for Policy, Pediatrics and International Collaboration
The Centre for Policy, Pediatrics and International Collaboration (CPPIC), in partnership with the Centres and Offices, provides centralized policy support to BRDD. CPPIC is responsible for the development and modernization of policies, standards, guidance, and directives supporting the regulation of biologics and radiopharmaceuticals, as well as frameworks regulating assisted human reproduction, blood and blood components, advanced therapeutics, and cells, tissues and organs for human transplantation. The CPPIC also provides Branch leadership on our approaches to patient involvement, health equity, medicines for pediatric patients, and engages with stakeholders to support the interface between national and international partners.
Office of Quality and Information Management
The Office of Quality and Information Management (OQIM) is responsible for coordinating the development, maintenance, integration, measurement, analysis, and continual improvement of the Directorate wide quality management system (QMS). The Office is also responsible for the development and implementation of an Information Management approach, which conforms to Health Canada and the Treasury Board Secretariat policies and best practices.
Office of Business Integration
The Office of Business Integration (OBI) provides horizontal organizational support to BRDD. This includes responsibility for corporate planning, performance and reporting, and audit and evaluation co-ordination. It is responsible for operational planning and budget allocations, along with business continuity and emergency plans. It leads the Directorate's Good Review Practices and manages the bilateral meeting program with stakeholders. Through its Administrative Services Unit, it provides a full range of administrative services (financial, human resources, material management) to BRDD management and employees.
Office of Regulatory Affairs
The Office of Regulatory Affairs (ORA) serves as the regulatory contact with sponsors for submission/application enquiries, provides regulatory guidance internally and externally, and coordinates pre-submission/application meetings for the Directorate. Manages submissions and applications associated with the drug products that the BRDD regulates. The responsibilities include, but are not limited to, the screening of submissions/applications in accordance with Health Canada's guidances and regulations, monitoring the adherence to submission/application review performance standards, sharing submission review information between BRDD and other trusted regulatory health authorities, and managing the receipt and issuance of submission/application related correspondences.
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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