The Biologics and Genetic Therapies Directorate (BGTD) is organized into three Centres and six Offices/Unit:
The BGTD's three Centres review and evaluate blood product, vaccine, radiopharmaceutical and biotherapeutic drug submissions to maximize the safety and efficacy of products prior to sale in Canada. The Centres also operate laboratories to analyze, test and conduct research on products, which contributes to the overall risk assessment. A risk-benefit analysis of the data submitted by a sponsor is carried out and may include an assessment of the manufacturing facility, known as an On-Site Evaluation (OSE), to assess the production process and facility, related to the product in question, since these have a significant impact on the safety and efficacy of a product. Additionally, the Centres monitor biologics by placing them on a lot release schedule tailored to the degree of risk associated with the product manufacturing, testing and inspection history. In addition, all Centres have formed partnerships and international networks to collaborate on the safety aspects of the products they regulate.
The Centre for Vaccine Evaluation (CVE) is responsible for the following products: viral vaccines, bacterial and combination vaccines. In addition, the CVE conducts regulatory scientific research supporting areas that include: vaccines, subsequent entry (generic) biologics, shelf life and stability of biologics, and emerging issues (e.g. stem cells, nano-scale drug delivery systems).
The Centre for Evaluation of Radiopharmaceuticals and Biotherapeutics (CERB) is responsible for the following products: radiopharmaceuticals, hormones, cytokines, enzymes, gene therapies, monoclonal antibodies, and allergenic extracts. In addition, the CERB evaluates the safety and clinical data for these products and for products in CVE.
The Centre for Blood and Tissues Evaluation (CBTE) is responsible for the following products: blood and blood components, coagulation factors, immune globulins and other plasma derivatives and their recombinant analogues, cells and cell-based medicines, tissues and organs, xenografts, semen for assisted conception. In addition, the CBTE evaluates the safety and clinical data for these products.
The Office of Policy and International Collaboration (OPIC) in partnership with the Centres, is responsible for developing new and updating existing policies, standards, guidelines, directives and other legislative / regulatory instruments regarding biologics and radiopharmaceuticals. Recognizing the value and necessity of leveraging international science and policy expertise, this Office conducts public and stakeholder consultations and coordinates international collaboration activities for the BGTD. In addition, OPIC carries out cost benefit analyses and project evaluations for all of the BGTD.
The Office of Regulatory Affairs' (ORA) core function is the management of submissions and applications associated with the products that the BGTD regulates. ORA, serving as the primary contact with industry, manages submission screening/validation, coordination and facilitation of submission meetings with industry, the receipt and issuance of all regulatory correspondence for the Directorate, and generates statistical reports on submission review performance. ORA is also responsible for data entry of all adverse drug reactions related to biological clinical trials.
The following offices/unit are part of the Director General's Office:
The Office of Quality and Information Management (OQIM) is responsible for coordinating the development, maintenance, integration, measurement and analysis, and continual improvement of the Directorate-wide quality management system (QMS). The BGTD's quality management system is based on ISO 9001 and integrates the requirements of ISO/IEC 17025. In support of the BGTD quality management system, the Office is responsible for implementing internal quality system audits, organizing management reviews, analysing QMS performance data, administering QMS databases, coaching process improvement, as well as coordinating the QMS training program. The Office is also responsible for the development and implementation of the Information Management approach used by the Directorate to ensure that Health Canada and Treasury Board Information Management policies and best practices are applied across the Directorate.
The Office of Business Integration and Risk Management (OBIRM) is responsible for coordinating the risk management function that facilitates timely and effective resolution of issues and ensures a coordinated and unified response on behalf of the Directorate. The Directorate's emergency preparedness and business continuity activities are also coordinated out of this Office along with the briefing and correspondence function for the BGTD. The Office also houses the Secretariat for the Directorate's Expert Advisory Committees and coordinates the review panels and requests for reconsideration of final decisions issued for human drug submissions. Additionally, this Office implements strategic initiatives and manages broad projects, both long term or emerging, and ensures the effective operation of the BGTD, including operational planning and performance measurement of the BGTD's projects related to the Biologics Program.
The Administrative Services Unit (ASU) provides administrative support and advice to all BGTD management and staff in the following areas: human resources and staffing, contract administration, purchasing of supplies and services, travel, budget tracking/variance reporting and maintaining position and personnel files for Directorate employees.