Regulatory Environment

Health Products & Food Branch

Health Canada’s Health Products and Food Branch (HPFB)'s mandate is to take an integrated approach to managing the health-related risks and benefits of health 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.

Regulating Health Products

Health Canada establishes science-based regulations, guidelines and policies for all health products. Health Canada’s 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. Biotechnology-based health products 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.

Therapeutic Products Directorate

Health Canada's Therapeutic Products Directorate (TPD) is the Canadian federal authority that regulates pharmaceutical drugs and medical devices for human use. 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.

Therapeutic Regulatory Process - http://www.hc-sc.gc.ca/ahc-asc/pubs/hpfb-dgpsa/access-therapeutic_acces-therapeutique_e.html

Medical Devices Active Licences Search

MDALL contains product-specific information on all medical devices that are currently licensed for sale in Canada, or have been licensed in the past. This system has been designed to help health care workers, who are contemplating the purchase of a Class II, III or IV medical device, to verify that the manufacturer has an active medical device licence. Since medical device licences can be suspended by Health Canada, cancelled during the annual renewal of licences by Health Canada, or discontinued by the manufacturer, it is important to conduct this verification each time the purchase of a medical device is considered.

Biologics and Genetic Therapies Directorate

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.

Health Canada's Biologics and Genetic Therapies Directorate (BGTD) is the Canadian federal authority that regulates biological drugs (products derived from living sources) and radiopharmaceuticals for human use. Prior to being issued a Notice of Compliance (NOC), a manufacturer must present substantive scientific evidence of a product's safety, efficacy and quality as required under the Food and Drugs Act and Regulations. Some of the products regulated by BGTD include, blood and blood products, viral and bacterial vaccines, gene therapy products, tissues, organs and xenografts, which are manufactured in Canada or elsewhere.

Regulated Biotech Products -- http://www.hc-sc.gc.ca/sr-sr/pubs/biotech/prod_bio_reg_e.html

Patent Register Search Page

The Patent Register is an alphabetical listing of medicines and the associated patents, patent expiry dates and other related information established in accordance with the Patented Medicines (Notice of Compliance) Regulations.

Drug Product Database

The DPD contains product specific information on drugs approved for use in Canada. The database is managed by Health Canada and includes human pharmaceutical and biological drugs, veterinary drugs and disinfectant products. It contains approximately 24,000 products which companies have notified Health Canada as being marketed. Information available in the database includes the following parameters: Brand Name, Drug Identification Number (DIN), Company, Ingredient(s), Route of Administration, Pharmaceutical Form, Package Sizes, Therapeutic Classification (AHFS and ATC), Active Ingredient Group (AIG) Number, Pharmaceutical Standard and Veterinary Species. Product and company information for drug products marketed in Canada can be found using the DPD ONLINE Query.

The Canadian Institutes of Health Research (CIHR) website contains information on guidelines for human pluripotent stem cell research.

Regulating Agricultural Biotechnology

The Canadian Food Inspection Agency (CFIA) shares responsibility with Health Canada for regulating products derived from biotechnology. The Agency is responsible for assessing the safety of plants, animal feeds and animal feed ingredients, fertilizers and veterinary biologics. CFIA is responsible for the development of non-health and safety food labelling regulations and policies.

Health Canada is responsible for assessing the human health safety of products derived through biotechnology including foods, drugs, cosmetics, medical devices and pest control products.

CFIA regulatory responsibilities include:

• Biotechnology-derived animals;
• Labelling of novel foods derived from genetic engineering;
• Novel feeds;
• Novel fertilizer supplements;
• Plants with novel traits; and
• Veterinary biologics produced by biotechnology

Biotechnology at Environment Canada

Animate products of biotechnology (living organisms) are covered by Part 6 of the Canadian Environmental Protection Act 1999. Furthermore, if these products are not specified on the Domestic Substances List (DSL), they are considered “New” and regulated by the New Substances Notification Regulations (Organisms).

Animate products of biotechnology refer to the use of living organisms such as micro-organisms that are used in microbial products or are used to produce various biomolecules. The Regulations also apply to various 'higher' organisms such as fish, livestock and insects (depending on the type of use). In some cases, Environment Canada has agreements with other Federal Departments to conduct assessments of certain types of organisms.

Briefly, the Regulations establish classes or groups of organisms; they identify administrative and information requirements; and they specify the timing of notification before import, or manufacture can proceed.

Learn how Canada regulates biotechnology applications ranging from cosmetics to drugs to medical devices. Find legislation, guidelines, and industry contacts and forms.

IPP for Patented Medicines

On October 18, 2006, the regulatory amendments to the Patented Medicines (Notice of Compliance) Regulations (“PM(NOC) Regulations”) and the data protection provisions in the Food and Drug Regulations were published in Part II of the Canada Gazette. The federal amendments to the data protection provisions in the Food and Drug Regulations will benefit innovative drug companies by guaranteeing a minimum eight-year period of market exclusivity for their products. A further six months of protection is available to drugs, which have been subject to paediatric studies.

This period of market exclusivity enables Canada to be internationally competitive with the EU and the US (i.e., the EU provides 10 years of data protection plus an additional year for new uses; the United States provides 5 years of data protection and 3 years for new uses). While the Canadian term of data protection is shorter than that provided by the EU, the Canadian system is as or more competitive overall because the Canadian data protection system is linked to the PM (NOC) Regulations, and together they provide for early-working generic drugs, while ensuring that the Intellectual Property on patented medicines is protected.

Intellectual Property Policy

Industry Canada’s Intellectual Property Policy group consists of two directorates: the Intellectual Property Policy Directorate (IPPD) and the Patent Policy Directorate (PPD).