Drug and health product review and approval

Information on the approval process for drugs, medical devices, natural health products and homeopathic medicine. Includes drug pricing and drug approval decisions.

Services and information

Regulatory decision summaries for drugs and medical devices

Understand the decisions to approve or deny the sale of drugs and medical devices in Canada.

Notice of compliance for approved drugs

Browse notices of compliance issued to manufacturers once a drug is approved.

Summary basis of decision for drugs and medical devices

Determine why a drug or medical device was approved for sale in Canada.

Regulating drug prices

Explore how prices are set on patented drugs.

Drug submissions under review

Research whether a submission for a new drug or a new use for an approved drug has been accepted for review in Canada.

How drugs are reviewed in Canada

Understand how drugs are reviewed to ensure they are safe and effective before being approved for sale in Canada.

Disclosure of confidential business information

Information on how we review requests to disclose confidential business information.

Canada's regulatory approach to drugs for rare diseases

Canada's regulatory approach, apply and register for clinical trials, find a clinical trial, find drug reviews and decisions.

Clinical information on drugs and health products

Find data about the tests and trials that were performed on drugs and medical devices to evaluate their safety and efficacy.

Regulating advanced therapeutic products

Canada’s regulatory approach for advanced therapeutic products, process, support for innovators, candidates.


What we are doing

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