Drug and medical device approval overview

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Clinical trials

Clinical Trials for drugs and Investigational Testing for medical devices represent potential new health care therapies which may eventually address the needs of Canadians.

Trial sponsors (including manufacturers and researchers) submit their applications to conduct a clinical trial with a drug or medical device in Canada. We review these applications and, if acceptable, we issue approvals to allow the trial to be conducted in Canada.

In 2017, Health Canada authorized 1229 new clinical trial applications for drugs, and 199 new investigational testing applications for medical devices.

You can find out what clinical trial applications have been approved for drugs in Canada by searching Health Canada's Clinical Trials Database.

Special access programs

Drugs and medical devices that are not approved may also be available through our Special Access Programs.

The Special Access Program for drugs provides access to drugs that cannot otherwise be sold or distributed in Canada.

The Special Access Program for medical devices provides access to custom-made or unlicensed devices.

In both programs, access is provided to the healthcare practitioner that is treating a patient. Access may be granted for emergency use or to patients with serious or life-threatening conditions when conventional therapies have failed, are unavailable or are unsuitable.

In 2017, Health Canada authorized 12,887 requests for special access to drugs, and 2,401 requests for special access to medical devices.

Drug and medical device submission and review

When a company decides that it would like to market a drug or medical device in Canada, it files an application to us for a new drug submission or new medical device licence.

Submissions for drugs and higher-risk medical devices are reviewed by our scientists. They perform a thorough review of the submitted information, sometimes using external consultants and advisory committees.

Reviewers evaluate the safety, effectiveness, and quality data to assess the potential benefits and risks of the drugs and medical devices. They also review the information to be provided to healthcare practitioners and consumers about the drug or medical device.

We publish a list of the new drug submissions that are currently under review. The list is updated monthly and includes the outcome of submissions that have reached a conclusion.

Expedited review pathways

We have various review processes that can provide an expedited path to a final decision for certain drugs and medical devices, including those that target specific health care needs. For example, in 2017 36% of the new drug submissions for new active substances were approved via an expedited pathway.

Priority review

Drug submissions and medical device applications that are granted priority review status are subject to an expedited review process.

Drugs or medical devices for serious, life-threatening, or severely debilitating diseases or conditions can be given a priority review status.

Notice of compliance with conditions

When a new drug is approved it is issued a Notice of Compliance (NOC). An NOC may be issued with conditions (NOC/c) to a drug with promising clinical benefit, for serious, life-threatening, or severely debilitating diseases or conditions. The manufacturer must still demonstrate that the drug has an acceptable safety profile based on a benefit/risk assessment and is of high quality.

Submissions that are reviewed under this pathway are also subject to an expedited review process.

Approval of drugs and medical devices

When a new drug is approved, it is issued a Notice of Compliance (NOC). When a new medical device is approved, it is issued a medical device licence.

This does not mean the drug or medical device will immediately be available to patients, as many other factors can influence that timeline.

In 2017, Health Canada approved 67 new drugs, including 36 new active substances. We approved 138 new generic drugs, and 3 biosimilars. We also approved 482 new Class III and IV medical devices, including 6 with novel technology.

New drugs approved

Find information for consumers about drugs that are currently marketed in Canada: Drug and Health Product Register.

Find a listing of all drugs approved for sale in Canada: Drug Product Database. In the database, many drugs are accompanied by their Product Monographs, which describe the conditions of use of the product.

Find the approvals (Notices of Compliance, or NOCs) issued for new drugs: Notice of Compliance database.

Find the purpose of a drug submission, and the reasons for our decision: Regulatory Decision Summary.

Find the detailed regulatory, safety, effectiveness and quality considerations that factored into our decision to approve certain drug submissions: Summary Basis of Decision.

New medical devices approved

Find the approvals (licences) issued for medical devices: Medical Devices Active Licences.

Find the purpose of an application for a medical device licence, and the reasons for our decision: Regulatory Decision Summary.

Find the detailed regulatory, safety, effectiveness and quality considerations that factored into our decision to approve certain medical devices: Summary Basis of Decision.

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