How medicines and medical devices get approved in Canada

A new drug cannot be sold in Canada until the maker files a new drug submission and the agency issues a notice of compliance. The rules require the submission to let the agency judge the drug's safety and effectiveness. Biologics, vaccines and cell and gene therapies use the same route.

Full application, new active substance · target 300 days · verified October 3, 2026

A drug with a known ingredient is still a new drug if its combination, use, dose or route is new in Canada. It is filed as a new drug submission. Significant changes to an approved new drug, such as a new indication, need a supplement and a new notice of compliance.

Full or mixed application, known active substance · target 300 days · verified October 3, 2026

Priority review gives eligible new drug submissions and supplements a shorter review target of 180 calendar days instead of 300. It is for drugs for serious conditions with substantial evidence of a major benefit.

Priority or accelerated review · target 180 days · verified October 3, 2026

A drug for a serious condition can be approved on promising evidence of effectiveness, with conditions such as confirmatory studies. The review target is 200 days. This policy is set to be replaced on April 1, 2027 by terms and conditions in the regulations.

Conditional or accelerated approval · target 200 days · verified October 3, 2026

Drugs to treat or prevent the effects of chemical, biological, radiological or nuclear exposure can be approved mainly on animal and other non-human evidence, because human efficacy trials are not possible. There is no fee.

Approval under exceptional circumstances · verified October 3, 2026

For drugs for a condition on the official list of public health threats, a new drug submission can be filed before all data are ready, with a plan for the missing parts. Approval rests on benefits outweighing risks given the public health need.

Rolling or phased review · verified October 3, 2026

Since July 15, 2026, the agency can treat its review of parts of a new drug submission (quality, non-clinical or clinical) as done, based on an approval by a listed foreign regulator. It applies only to drug classes on an official list, which starts with mainly pediatric uses.

Reliance route, abridged review · relies on AU, CH, EU, GB, US · verified October 3, 2026

Canada works with Australia, Singapore, Switzerland and the United Kingdom to review the same new active substance file together. Each regulator reviews assigned modules, and each makes its own decision. Since July 2026, parts examined by a partner in a joint review can be deemed reviewed in Canada.

Work-sharing or joint review · target 300 days · relies on AU, CH, GB, SG · verified October 3, 2026

Canada joins the US FDA and other partners to review promising cancer drugs at the same time. Canadian review standards do not change, but some decisions can come sooner. Each regulator decides on its own.

Work-sharing or joint review · relies on AU, BR, CH, GB, SG, US · verified October 3, 2026

Doctors and other practitioners can ask for a drug that is not sold in Canada to treat a patient in a medical emergency. The agency authorizes the maker to sell a set quantity to that practitioner.

Early or compassionate access · relies on EU, US · verified October 3, 2026

Canada has no separate law route for biosimilars. A biosimilar is filed and reviewed as a new drug submission, with data showing it is highly similar to a reference biologic authorized in Canada.

Biosimilar application · target 300 days · verified October 3, 2026

A generic copy of an approved new drug is filed as an abbreviated new drug submission. The rules require it to be the pharmaceutical equivalent of, and bioequivalent with, a Canadian reference product, with the same route and conditions of use.

Generic application · target 180 days · verified October 3, 2026

Many non-prescription drugs that are not new drugs get a drug identification number (DIN) by attesting that they meet a labelling standard or Category IV monograph. No clinical or manufacturing data are filed.

Non-prescription monograph · target 60 days · verified October 3, 2026

Drugs that are not new drugs, including many non-prescription products, get a drug identification number through a DIN application. When the product does not fit a labelling standard, the application includes supporting data.

Non-prescription application · target 210 days · verified October 3, 2026

Canada has no separate route for drug and device combination products. The agency decides whether the whole product follows the drug rules or the device rules, based on its principal mechanism of action. The product then uses that route.

Other route · verified October 3, 2026

Class I devices, the lowest risk, do not need a device licence. Companies that import or sell them need a medical device establishment licence, and the safety and effectiveness rules still apply to manufacturers.

Device: exempt or self-declared · verified October 3, 2026

Class II devices need a medical device licence. The application rests on an attestation that the maker holds objective evidence of safety and effectiveness, plus a quality system certificate. The review target is 15 days.

Device: registration or licence with the regulator · target 15 days · verified October 3, 2026

Class III devices need a medical device licence based on a summary of the studies that show safety and effectiveness, the device's history in other countries, and a quality system certificate. The review target is 60 days to a first decision.

Device: premarket approval by the regulator · target 60 days · verified October 3, 2026

Class IV devices, the highest risk, need a medical device licence backed by detailed study data, a risk assessment, a quality plan and a quality system certificate. The review target is 75 days to a first decision.

Device: premarket approval by the regulator · target 75 days · verified October 3, 2026

Health care professionals can ask for a custom-made or unlicensed device for patients with an exceptional need. Emergencies get priority, and the agency aims to reply to other requests within 3 working days.

Early or compassionate access · verified October 3, 2026