Health Canada
www.hc-sc.gc.ca
Common menu bar links
Institutional links
Health Products
Biotechnology has the potential to give Canadians a wide variety of new and important products to prevent disease, treat illness, and help us improve our health. Broad definitions of "biotechnology-derived" incorporate all products biologically sourced or using biological systems in their manufacturing; some definitions expand the concept to include peptides and nucleic acid oligomers that are chemically synthesized; whereas a limited definition might restrict products to those prepared using recombinant DNA procedures or "modern" cell culture techniques.
Biotechnology-based health products can therefore include:
- Biologics (biological drugs) such as: conventional viral and bacterial vaccines, and products derived from animal and human fluids, tissues and organs; recombinant proteins including, blood products, hormones, growth factors and enzymes manufactured in bacterial, yeast or mammalian cell lines; and gene therapy and cell therapy products;
- Radiopharmaceuticals that contain a biotechnology-derived component;
- Pharmaceuticals regulated as chemical drugs, such as: certain antibiotics and enzymes; and
- Medical devices and certain diagnostic tests and kits.
Some of the diseases currently treated or diagnosed with biotechnology-based health products are diabetes, haemophilia, rheumatoid arthritis, multiple sclerosis, and cancer.
Health Canada establishes science-based regulations, guidelines and policies for all health products. Our main concerns in regulating biotechnology-based products are the health and safety of Canadians. Any concerns about the risk profile of a product are investigated and considered.
This section has information on how we use laboratory experiments and testing and policies and regulations to ensure that biotechnology-based health products are efficacious and of high quality.
You can learn how we minimize health product-related risks throughout the product life cycle. This involves activities concerning:
- Pre-clinical studies;
- The review and evaluation processes used to evaluate the safety, quality and efficacy of health products;
- Compliance and enforcement regulations; and
- How health and biotechnology products are monitored and tracked once they are available to the Canadian public (post-market surveillance).
You will also find descriptions of products derived from biotechnology in the A - Z glossary.
