Drug Products

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.

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 list includes the medicinal ingredient(s) and therapeutic area for new active substances that are accepted into review on or after April 1, 2015.

Summary Basis of Decision documents are available, which outline the scientific and benefit/risk based decisions that factor into Health Canada's decision to grant market authorization for a drug or medical device.

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.

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