Submission 'class'
Notice to stakeholders
As of March 20, 2026, the lists of submissions completed now include the submission ‘class’, including if submissions were reviewed under the Access Consortium or Project Orbis.
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.
As of March 20, 2026, the lists of submissions completed will include the submission ‘class’, including if submissions were reviewed under the Access Consortium or Project Orbis.
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 organization
- For use in relation to COVID-19
- Project Orbis
- Reviewed under the Access Consortium: New Active Substance Work Sharing Initiative
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).
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.
Learn more about Biosimilar Biologic Drugs in Canada.
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.
Learn more:
- Priority review of drug submissions policy
- 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). A 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.
Learn more about 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.
Part of an 'aligned review' with a health technology assessment organization
An 'aligned review' is one where the sponsor allows information to be shared between Health Canada and Canadian health technology assessment (HTA) organizations during parallel reviews filed to Health Canada and these HTAs. 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 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.
Project Orbis
This submission ‘class’ applies exclusively to the lists of submissions completed.
Project Orbis is an initiative of the U.S. Food and Drug Administration (FDA) Oncology Center of Excellence. Project Orbis partners, including Health Canada, are regulatory agencies that collaborate with the FDA on the review of submissions for cancer drugs. Sponsors need to address the FDA with their initial inquiries about submitting through the Project Orbis pathway.
There are currently 3 types of Project Orbis collaboration. They are classified based on the submission and review timelines between the FDA and the participating Project Orbis partners.
Learn more about Project Orbis.
Reviewed under Project Orbis Type A
Type A Orbis are those in which sponsors file their submission to Health Canada within 30 days of submitting it to the FDA.
Reviewed under Project Orbis Type B
Type B Orbis are those in which sponsors file their submission to Health Canada more than 30 days after submitting it to the FDA but prior to the FDA issuing a final regulatory decision on market authorization.
Reviewed under Project Orbis Type C
Type C Orbis are those in which sponsors file their submission to Health Canada after the FDA has already granted market authorization.
Reviewed under the Access Consortium: New Active Substance Work Sharing Initiative
This submission ‘class’ applies exclusively to the lists of submissions completed.
The Access Consortium is a group of like-minded regulatory authorities that work together to promote regulatory collaboration and greater alignment of regulatory requirements to improve access to safe and effective health products.
The New Active Substance Work Sharing Initiative (NASWSI) is the Access Consortium’s pathway for the collaborative regulatory review of submissions for innovative drug products. When drug submission sponsors opt to leverage this pathway and file parallel submissions to 2 or more of the member countries, the participating regulators will collaborate on the scientific review of the submission to maximize efficiency and harmonization.
Learn more about the Access Consortium.
Contact us
Questions can be sent to us by email at hc.opprs.enquiries-enquettes.bprse.sc@canada.ca.