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.
Contributors
What we are doing
Laws and regulations
Publications
- Health product highlights 2021: Helping you maintain and improve your health
- Mid-year update: Health products approved in 2021
- Drug and medical device highlights 2020: Helping you maintain and improve your health
- Mid-year update: Drugs and medical devices approved in 2020
- Drug and medical device highlights 2019: Helping you maintain and improve your health
- Guidance document on Public Release of Clinical Information
Consultations
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