Submission 'Class'

Health Canada announced in August 2018 that implementation of Phase III of the Submissions Under Review (SUR) List initiative will proceed. For eligible submissions (new drug submissions and eligible supplemental new drug submissions) accepted into review on or after October 1, 2018, the submission 'class' will be added to the Lists of submissions currently under review.

The submission 'classes' are the following:

• Extraordinary use submission
• New active substance
• Biosimilar
• Being reviewed under the Priority Review Policy
• Being reviewed under the Notice of Compliance with Conditions Guidance
• Being reviewed under the Submissions Relying on Third-Party Data Guidance
• Part of an 'aligned review' with a health technology assessment (HTA) organization
• For use in relation to COVID-19

Below, you will find an explanation of each of these terms.

Extraordinary use submission

Health Canada recognizes that there are circumstances in which manufacturers cannot reasonably provide substantial evidence demonstrating the safety and efficacy of a therapeutic product as there are logistical or ethical challenges in conducting the appropriate human clinical trials. For these types of products, which may be needed as part of emergency preparedness in Canada, the regulations for Extraordinary Use New Drugs (EUND) allow for the possibility of a market authorization based primarily on animal data.

Once a product has received market authorization as an EUND, the sale of the product for that indication is restricted to federal, provincial and territorial, and municipal government(s).

For more information, refer to the Guidance Document - Submission and Information Requirements for Extraordinary Use New Drugs (EUNDs).

New active substance

A new active substance is a new drug (pharmaceutical or biologic) that contains a medicinal ingredient not previously approved in a drug in Canada and that is not a variation of a previously approved medicinal ingredient.

Biosimilar

A biosimilar biologic drug, or biosimilar, is a biologic drug demonstrated to be similar to a brand name drug already authorized for sale (known as the reference biologic drug). Biosimilars were previously known in Canada as subsequent entry biologics (SEBs). Biosimilars may enter the market after the expiry of reference biologic drug patents and data protections.

For more information, refer to the Fact Sheet on Biosimilars.

Being reviewed under the Priority Review Policy

Drug submissions that are granted priority review status are subject to an expedited review process. Drugs for serious, life-threatening, or severely debilitating diseases or conditions can be given a priority review status.

For more information, refer to the Priority Review of Drug Submissions Policy or the Guidance for Industry - Priority Review of Drug Submissions.

Being reviewed under the Notice of Compliance with Conditions Guidance

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 subject to an expedited review process.

For more information, refer to the Guidance Document: Notice of Compliance with Conditions (NOC/c).

Being reviewed under the Submissions Relying on Third-Party Data Guidance

In some cases, new drug submissions or supplements may substantially rely on literature and market experience, instead of clinical study reports. Although these submissions may differ in the source of information used to support safety and effectiveness, they meet the same standards of approval as a conventional submission.

For more information, refer to the Guidance Document: Drug Submissions Relying on Third-Party Data (Literature and Market Experience).

Part of an 'aligned review' with a health technology assessment (HTA) organization

An 'aligned review' is one where the sponsor allows information to be shared between Health Canada and Canadian health technology assessment (HTA) organizations. The goal is to cut the time between Health Canada's market approval and HTA funding recommendations to federal, provincial, and territorial drug plans and cancer organizations. This has the potential to speed up access for patients to drugs.

For more information, refer to the Notice to industry: Aligned reviews between Health Canada and health technology assessment organizations.

For use in relation to COVID-19

This refers to a submission for a drug (a treatment or a vaccine) filed under the Food and Drug Regulations for use in the COVID-19 pandemic.

Questions can be sent to us by email.