Health Products

Health Canada plays an active role in ensuring that Canadians have access to safe and effective health products. The Department strives to maintain a balance between the potential health benefits and risks posed by all health products.

All health products, including those that contain nanomaterials are regulated by the  Food and Drugs Act, and associated Regulations. This Act provides Health Canada with the authority to regulate the safety, efficacy, and quality aspects of health products. The associated regulations cover all aspects of the manufacturing, clinical testing, safety and efficacy assessment, and post-market surveillance of health products including those that contain nanomaterials. These products are subject to the same rigorous regulations that apply to conventional health products.

In addition, the  Canadian Environmental Protection Act, 1999 (CEPA 1999) provides Health Canada and Environment Canada  authority to assess the environmental and human-health risks associated with the release into the environment of substances in health products that contain nanomaterials.

More information on various health products is provided below. 


All drug products, including those containing nanomaterials are regulated under the  Food and Drug Regulations.

Drugs include: 1) prescription and nonprescription pharmaceuticals; 2) biologically-derived products (such as vaccines, serums, and blood derived products); 3) tissues and organs; 4) disinfectants; and 5) radiopharmaceuticals. Natural health products, such as vitamin and mineral supplements and herbal products, for which therapeutic claims are made are also regulated as drugs.

Before drug products are authorized for sale in Canada, Health Canada reviews them to assess their safety, efficacy and quality. Drug products include prescription and non-prescription pharmaceuticals, disinfectant products.

Prior to being given market authorization, a manufacturer must present substantive scientific evidence of a product's safety, efficacy and quality as required by the Food and Drugs Act and Regulations.

Prescription and Non-Prescription Pharmaceuticals

Health Canada regulates pharmaceuticals through strict regulation and high standards.  Prior to being given market authorization, a company must submit substantive scientific evidence of a product's safety, efficacy and quality as required by the Food and Drug Regulations. Health Canada reviews this evidence to determine whether the potential risks from the new pharmaceutical is acceptable when balanced against the positive effects.

Before any drug product is authorized for sale in Canada, Health Canada evaluates the product's safety, efficacy, and quality.

For more information on the regulation of drug products, please visit: Drug Products.

Biologics and Radiopharmaceuticals

Like other drug products in Canada, biological drugs, which include vaccines, biotechnology products, and radiopharmaceuticals containing nanomaterials, are regulated under  Food and Drug Regulations.

Because the methods used to manufacture biologics are quite variable, more detailed information about the chemistry and manufacturing (quality) of any biologic drug is required as part of the information Health Canada uses for risk assessment. If nanomaterials or processes involving nanotechnology are part of the manufacturing process for a biologic, or are included in a biologic drug, this information would be identified during the risk assessment.

Health Canada works to maximize the safety and effectiveness of all biologic drugs, and to ensure that products authorized for sale in Canada are of high quality, safe, and efficacious.

For more information on the regulation of biological drugs, please visit: Biologics, Radiopharmaceuticals and Genetic Therapies.

Veterinary Drugs

Veterinary drugs are drug products indicated for use in food producing and companion animals. The regulation of these drugs also focuses on the evaluation of the safety, quality and effectiveness of these products. It includes establishing standards for veterinary drugs, e.g., the maximum residue limits of drug residues in food producing animals. An important aspect of the scientific evaluation is a consideration of the product's benefit vs. risk.

For more information on the regulation of veterinary drug products, please visit: Veterinary Drugs.

Disinfectant Drug Products

A disinfectant product may be classified as either a drug or a pest-control product. Like all other drugs and pest-control products, disinfectant products that contain nanomaterials are regulated under the  Food and Drug Regulations or  Pest Control Product Regulations. Before they can be sold in Canada, the manufacturer must provide sufficient information to allow assessment of their potential human health and safety risks.

For more information on the regulation of disinfectant products, please visit: Disinfectants.

Natural Health Products

Natural Health Products (NHPs) are regulated under their own specific regulations, the Natural Health Products Regulations (NHPR), which take into account the unique nature and properties of these products.  All NHPs sold in Canada, including those containing nanomaterials, must have a product licence, and the Canadian sites that manufacture, package, label and import these products must have site licences. The NHPR give Canadians ready access to a wide range of NHPs that are safe, effective and of high quality. In Canada, NHPs are defined as: vitamins and minerals; herbal remedies, homeopathic medicines; traditional medicines such as traditional Chinese medicines; probiotics, and other products such as amino acids and essential fatty acids.  NHPs must be safe to use as over-the-counter products and not need a prescription to be sold.

For more information on natural health products, please visit: Natural Health Products.

Medical Devices

The term "medical device" covers a wide range of products used in the treatment, mitigation, diagnosis or prevention of a disease or abnormal physical condition. Some examples include pacemakers, artificial heart valves, hip implants, synthetic skin, medical laboratory diagnostic instruments, and test kits for diagnosis and contraceptive devices.

Like all medical devices the Medical devices that contain nanomaterials are regulated under the  Medical Devices Regulations. All medical devices have been categorized based on the risk associated with their use. This approach means that all medical devices are grouped into four classes with Class I devices presenting the lowest potential risk (e.g. a thermometer) and Class IV devices presenting the greatest potential risk (e.g. pacemakers). Prior to selling a device in Canada, manufacturers of Class II, III and IV devices must obtain a Medical Device Licence. Although Class I devices do not require a Licence, they are monitored through Establishment Licences.

Health Canada reviews high risk medical devices to assess their safety, effectiveness, and quality before they are authorized for sale in Canada. 

For more information on regulation of medical devices, please visit: Medical Devices.

For additional information on nanotechnology-based health products and food please visit: Nanotechnology-Based Health Products and Food.

Assessments of Substances Found in Health Products under Canadian Environmental Protection Act, 1999 (CEPA 1999)

Under CEPA 1999, Health Canada together with Environment Canada conducts assessments of the potential environmental and human health risks arising from environmental exposure to new substances, including nanomaterials, in products regulated under the Food and Drugs Act and its regulations when that substance is manufactured or imported in excess of the quantities set out in the New Substances Notification Regulations (NSNR).

For more information on assessments of health products under CEPA, 1999 please visit: Environmental Impact Initiative.

Post-market Surveillance

The Marketed Health Products Directorate (MHPD) works to assure that Health Products and Food Branch (HPFB) programs responsible for the regulation of nanomaterials in health products take a consistent approach to post-approval safety surveillance, assessment of signals and safety trends and risk communications concerning all regulated marketed health products.

For more information on the activities involved in marketed health products, please visit: Marketed Health Products Directorate.

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