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, disinfectants and sanitizers with disinfectant claims.
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.
When a product is offered for sale in Canada to treat or prevent diseases or symptoms, it is regulated as a drug under the Food and Drugs Act.
Additional information on how drugs are approved and authorized in Canada is available on the fact sheet "How Drugs are Reviewed in Canada".
What information can you find here?
This section contains fee information, guidance documents, forms and policies needed to submit all the different types of applications.
The Activities section contains information supporting Health Canada's regulation of drug products, including announcements, consultations and fact sheets as well as various projects and committees.
Complete listings of Advisories, Warnings and Recalls for health professionals and the public are available on the MedEffect Canada section.
There are links to our Patent Register Database, an alphabetical listing of patented medicines, and our Drug Product Database, which contains product and company information on drug products marketed in Canada. There is also a link to the Notices of Compliance.
The Submissions Under Review lists include the medicinal ingredient(s) and therapeutic area for new drug submissions and supplements for new uses that are currently under review.
Regulatory Decision Summaries (RDSs) explain Health Canada's decision for certain health products seeking market authorization. The RDSs include the purpose of the submission and the reason for the decision. These pages also include summaries of certain submissions that were accepted into review and subsequently cancelled by the sponsor.
Summary Basis of Decision documents explain why Health Canada authorized certain drugs and medical devices for sale in Canada. The SBDs include regulatory, safety, effectiveness and quality (chemistry and manufacturing) considerations.
We also provide information to support the role of the federal regulatory authority such as the International Harmonization of drugs for human use, Science Advisory Committees, Association Meetings and Performance Reports. Many of these activities are carried out with the participation of clients, stakeholders and the general public.
The Progressive Licensing Project has been initiated to develop a drug regulatory system for the future, and gives details of the plan for developing a new framework, and provides an opportunity for discussion with Canadians regarding drug licensing.
Information about nanotechnology-based health products and food.
- Food and Drugs Act Liaison Office
- Prescription Drug List
- Cough and Cold Medicine for Children
Health Canada is requiring manufacturers to relabel over-the-counter cough and cold medicines with certain active ingredients to indicate that they should not be used in children under 6.
- Food and Consumer Safety Action Plan
- Search recalls and safety alerts
- Products at the Cosmetic-Drug Interface
These are products that may share the characteristics of both "cosmetic" and "drug", as defined in the Food and Drugs Act, making them more difficult to classify.
- Medical Devices
- Related Links
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