Transcript Document
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 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 HEALTH PRODUCTS AND FOOD BRANCH Assistant Deputy Minister Diane C. Gorman Senior Director General Janet King Therapeutic Products Directorate Director General Robert Peterson Biologics and Genetic Therapies Directorate A/Director General Julia Hill Natural Health Products Directorate Director General Philip Waddington Health Products and Food Branch Inspectorate Director General Jean Lambert Office of Regulatory and International Affairs Director General Elizabeth Nielsen Office of Biotechnology and Science Director General Pierre Charest Food Directorate Director General Karen Dodds Veterinary Drugs Directorate Director General Diane C. Kirkpatrick Office of Nutrition Policy and Promotion A/Director General Mary Bush Marketed Health Products Directorate Director General A/Chris Turner Policy and Strategic Planning Directorate A/Director General Janet Pronk Health Products and Food Litigation Secretariat Director General Susan Padmos Office of Consumer and Public Involvement Director General Roger Farley 3 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 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 STRUCTURE OF THE DIRECTORATE A /D ire c to r G e n e ra l J u lia H ill A s s o c ia te D ire c to r G e n e ra l A d m in is tra tio n S e rv ic e s D r. E lw y n G riffith s C e n tre fo r P o lic y & R e g u la to ry A ffa irs D ire c to r, L a u ra R e in h a rd B lo o d E s ta b lis h m e n t R e g u la tio n D iv is io n P o lic y a n d P ro m o tio n D iv is io n O ffic e o f S tra te g ic & O p e ra tio n a l P la n n in g R is k Is s u e s M a n a g e r O ffic e o f Q u a lity M a n a g e m e n t S u b m is s io n M a n a g e m e n t D iv is io n In c lu d in g O S E S c h e d u lin g C e n tre fo r B io lo g ic s R e s e a rc h D ire c to r, D r. A lla n J . M o rtim e r B io lo g ic s & R a d io p h a rm a c e u tic a ls E v a lu a tio n C e n tre C e llu la r & M o le c u la r B io lo g y D iv is io n B io th e ra p e u tic s D iv is io n V a c c in e s D iv is io n C lin ic a l E v a lu a tio n D iv is io n B lo o d , T is s u e s a n d O rg a n s D iv is io n B io m o le c u la r a n d S tru c tu ra l C h e m is try D iv is io n 5 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 WHAT WE DO Product areas: -Vaccines -Blood products -Blood establishments -Biotherapeutic products Activity areas: -Product Evaluation: pre and post approval -Policy and Regulations -Research and Method Development Funded through tax dollars and fee for service -Radiopharmaceuticals -Organs, tissues Product Evaluation: -Clinical trial review, projects for biological and radiopharmaceutical drugs -Pre- and post-market review services -Pre- and post-market laboratory support 6 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 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