Guide

Marketing a new drug in Canada: prepare the sponsor’s regulatory submission

Check first

An authorized clinical trial or establishment licence is not a marketing authorization for the product.

Confirm the right process

Confirm with the regulatory team whether the product requires a new drug submission, an abbreviated submission or another route.

Prepare the dossier

Assemble product-specific quality, manufacturing, non-clinical and clinical evidence, the monograph, labels and administrative information.

Submit the application

Use current forms and electronic formats; request a pre-submission meeting when the pathway or evidence presents a difficulty.

Follow up

Answer review requests and verify the authorizations actually issued before sale; then arrange ongoing regulatory obligations.

Official procedure

Requirements and supporting information

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Official sources consulted August 30, 2026. Orientation guide: confirm current rules, documents, deadlines and conditions with the responsible authority.

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