Health Canada : Food and Drugs Act and Regulations

Health Canada is responsible for establishing standards for the safety and nutritional quality of all foods sold in Canada. The department exercises this mandate under the authority of the Food and Drugs Act and pursue its regulatory mandate under the Food and Drug Regulations. All health and safety standards under the Food and Drug Regulations are enforced by the Canadian Food Inspection Agency. The Agency is also responsible for the administration of non-health and safety regulations concerning food packaging, labelling and advertising. Health Canada can no longer issue Interim Marketing Authorizations (IMAs), as the ability to do so has been replaced in the Food and Drugs Act with the Marketing Authorization authority. Food in Canada must comply with a range of regulations to ensure our health and safety. Legislature for food in Canada includes the Food and Drugs Act, Safe Food for Canadians Act, Consumer Packaging and Labelling Act, and more depending on the nature of the food. The primary legislature for food in Canada is the Food and Drugs Act (FDA). All drugs that are marketed in Canada are subject to the Food and Drugs Act and Regulations. The Biologics and Genetic Therapies Directorate is responsible for the review and approval of all types of drug submissions for Biological (Schedule D) and Radiopharmaceutical (Schedule C) drug products, including, but not limited to New Drug Submissions (NDSs) and Clinical Trial Applications (CTAs). For the regulatory requirements specific to Radiopharmaceutical (Schedule C to the Act) or Biological (Schedule D to the Act) drugs, please refer to Divisions 3 and 4, respectively, of Part C of the Regulations. For general regulatory requirements concerning all drugs, including Good Manufacturing Practices, please refer to Divisions 1, 1a, 2, 5 and 8 of Part C of the Regulations.

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Health Canada works to maximize the safety and effectiveness of biologics, including vaccines and biotechnology products, as well as, radiopharmaceuticals in the Canadian marketplace and health system. The Biologic and Radiopharmaceutical Drugs Directorate (BRDD) applies the Food and Drug Regulations under the authority of the Food and Drugs Act to ensure that drugs defined by Schedule C and Schedule D of the Act for human use in Canada are safe, effective and of high quality. The BRDD is committed to developing any new regulations, policies, and guidelines in consultation with stakeholders and interested parties. The links provided introduce the regulatory initiatives.

Before a biologic can be considered for approval, sufficient scientific evidence must be collected to show that it is safe, efficacious and of suitable quality. Biologics differ from other drugs for human use in that they must – in addition to the information required for other drugs – include more detailed chemistry and manufacturing information. This is necessary to help ensure the purity and quality of the product, for example to help ensure that it is not contaminated by an undesired microorganism or by another biologic.

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The FDA outlines laws on food labelling, advertising and claims; food standards and compositional requirements; fortification; foods for special dietary uses; food additives; chemical and microbial hazards; veterinary drug residues; packaging material; and pesticides. There are three federal government departments that play complementary roles in the development, enforcement and interpretation of policies and guidance stemming from the FDA and its Food and Drug Regulations (FDR).

  • Health Canada is responsible for setting standards for the nutritional quality and safety of all foods sold in Canada. The Food Directorate, within the Health Products and Food Branch, manages the health risks and benefits of food products by evaluating scientific evidence to develop and implement requirements under the FDA and its associated policies and standards. They exercise this mandate under the authority of the FDA, and its regulatory mandate is pursued under the FDR.
  • The Canadian Food Inspection Agency (CFIA) is responsible for enforcing health and safety standards outlined in the FDA and its associated regulations. The CFIA’s main concern is to mitigate risks to food safety, and the Agency is also responsible for administrating non-health and safety regulations regarding packaging, labelling and advertising.
  • Agriculture and Agri-Food Canada (AAFC) helps to get innovative food products into the marketplace by providing information and support to help the industry understand regulatory requirements associated with the FDA.

The FDA ensures that Canadians can make informed food decisions based on truthful and not misleading information. For this reason, the FDA insists on honest food labelling, and requires industry to comply with regulations on food labelling, advertising and claims. Nutrition and health claims must be scientifically validated, and constructed to provide the consumer with meaningful information.

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