1. Biologics and Genetic Therapies Directorate Health Products and Food Branch HEALTH CANADA Helping Canadians maintain and improve their health. Agnes Klein Clinical Evaluation Division February 6, 2003

2. MANDATE The mandate of the Health Products and Food Branch through an integrated approach to the management of the risks and benefits to health related products and food by:  Minimizing health risk factors to Canadians while maximizing the safety provided by the regulatory system for health products and food; and,  Promoting conditions that enable Canadians to make healthy choices and providing information so that they can make informed decisions about their health. 2

3. HEALTH PRODUCTS AND FOOD BRANCH 3

4. Mandate The mandate of the Biologics and Genetic Therapies Directorate will be derive directly from the Branch’s mandate, but specifically applies to those products for which the Directorate is responsible: biologics, genetic therapies and radiopharmaceuticals

5. VISION 1.We will be recognized nationally and internationally as the Canadian regulatory authority for the management of the benefits and risks of biologics and radiopharmaceuticals for human use. 2.We will generate, develop and share new knowledge, independently and through partnerships, in order to advance the understanding and promotion of health, and the prevention, diagnosis and treatment of illness. 3.We will proactively address new scientific issues and regulatory challenges, always keeping in mind our mandate and our link to public health, and continuously improving service to the people of Canada. 4.We will build a shared sense of purpose and direction which is understood by all employees; a culture based on trust and respect; and a working environment which allows us all to work productively and harmoniously 4

6. STRUCTURE OF THE DIRECTORATE 5

7. A few comments Current Issues –Blood safety and sufficiency –Timely evaluation and decisions on products Priority Reviews Preventative vaccines –Regulatory frameworks Blood Tissues Organs and Xenografts Speech from the Throne –Renewal of Health Protection Legislation –Speed up regulatory process for drug review and approvals –Smart regulation strategy

8. WHAT WE DO Product areas:Activity areas: -Vaccines-Product Evaluation: pre and post approval -Blood products-Policy and Regulations -Blood establishments -Biotherapeutic products-Research and Method Development -RadiopharmaceuticalsFunded through tax dollars and fee -Organs, tissuesfor service Product Evaluation: -Clinical trial review, projects for biological and radiopharmaceutical drugs -Pre- and post-market review services -Pre- and post-market laboratory support 6

9. WHAT WE DO Policy and Regulations: -Regulatory Frameworks for Blood and Blood components, Cells, Tissues and Organs, and Xenografts -Orgnan and Tissue Donation and Transplantation Policy and Promotion -Standards ( In collaborarion with CSA) -Public involvement -Promotion of informed use of our products Research: -Maintain and enhance research capacity -Enhance expertise in biotechnology -Integrate genomics and proteomics approaches to research on safety and efficacy 7

10. Food and Drugs Act and Regulations Food and Drugs Act and Regulations as part of the Criminal Code: it is antifraud legislation Definition of a Drug Definition of a New Drug General Regulatory Requirements –Safety Efficacy and Quality Authority to sell a drug Adequate Directions for use Clinical Trial Regulations are an exception to all of the above