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We regulate the following biotechnology-based health products:
Biologics are drugs regulated by Health Canada which are listed in Schedule D to the Food and Drugs Act. Biologics are essentially defined by their listing in Schedule D, however, it is generally accurate to say that biologics are made from or through the action of living organisms, whether natural or genetically modified. Examples include:
- Immunizing agents such as, conventional viral and bacterial vaccines, and those produced using recombinant DNA technology;
- Products derived from animal and human fluids, tissues and organs, such as snake venoms, immune globulins, and human blood components;
- Recombinant proteins manufactured in bacterial, yeast or mammalian cell lines including, blood products, hormones such as insulin, interferons, growth factors, enzymes, and monoclonal antibodies; and
- Gene therapy and cell therapy products.
Radiopharmaceuticals are listed in Schedule C to the Food and Drugs Act. Examples include:
- Kits containing biotechnology-sourced products that are intended to be radiolabelled via linkage to a radionuclide.
- Certain antibiotics and enzymes produced via microbial fermentation;
- Heparins; and
- Chemically synthesized peptides and oligomers.
- Devices to detect nucleic acid (DNA, RNA) by any Polymerase Chain Reaction (PCR)-based assays. These devices, which allow for the amplification of viral DNA/RNA in infected human specimens are used in the diagnosis of such conditions as Hepatitis B, Hepatitis C, HIV, and Sexually Transmitted Infections (STIs);
- Devices that use microorganisms or their elements (genes, proteins, enzymes) to transform or make a product and used in Enzyme-Linked Immuno Assays (EIA) such as ELISA, for the detection of infections (Hepatitis B, Hepatitis C, HIV, West Nile Virus, STDs) or tumour markers;
- Devices produced by fermentation for injection into joints. These are used for tissue augmentation and/or treatment of arthritis; and
- Artificial skins (tissue-cultured skin replacement products).
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