Drug and Health Product Submissions Under Review (SUR)
How to access lists of certain drug submissions under review, and lists of certain drug submissions completed.
On this page
- Submissions under review for use in relation to COVID-19
- About the SUR Lists
- Finding information on the lists
- Decisions
- Contact us
Submissions under review for use in relation to COVID-19
The Submissions Under Review (SUR) Lists include submissions filed under both the Interim Order Respecting the Importation, Sale and Advertising of Drugs for Use in Relation to COVID-19 and the Food and Drug Regulations for use in relation to COVID-19. These submissions are identified under the submission 'class' column for submissions under review, and under the medicinal ingredient column for completed submissions. To find these submissions, type "COVID" into the "Filter items" box at the top of the lists.
In some cases, applicants have filed a new drug submission under the Food and Drug Regulations, to transition a product previously authorized under the Interim Order Respecting the Importation, Sale and Advertising of Drugs for Use in Relation to COVID-19. These products continue to be approved for sale in Canada during this transition period and are clearly identified in the applicable row.
For more information about products that have been authorized for use in relation to COVID-19, visit the COVID-19 vaccines and treatments portal.
About the SUR Lists
The SUR Lists help to make our review processes more transparent. The lists will help Canadians:
- make better decisions about their health
- identify substances accepted for review in Canada
The lists have been implemented in phases. You can find more information about the phased approach in the Notices published in April 2016 (Phase I and II) and August 2018 (Phase III).
The Submissions Under Review (SUR) Lists include new drug submissions containing new active substances (pharmaceuticals and biologics with an active ingredient not approved in Canada). This applies to submissions accepted for review on or after April 1, 2015.
The lists also include submissions accepted for review on or after May 1, 2016, specifically:
- new drug submissions
- supplemental new drug submissions for new uses
A separate list is published for generic submissions (abbreviated new drug submissions) accepted into review on or after October 1, 2018. Click here to see the Generic Submissions Under Review (GSUR) List.
Finding information on the lists
There are four Submissions Under Review (SUR) Lists, which contain:
- new drug submissions under review
- supplemental submissions under review
- new drug submissions completed
- supplemental submissions completed
All four lists are updated monthly. A substance is moved from the list of submissions under review to the list of submissions completed when it reaches a conclusion (it is cancelled, or a final decision is made).
Download the Excel version (XLSX format, 211 KB)
The SUR lists are current as of: 2025-04-30
Lists of submissions under review
The entry for each submission on the lists of submissions under review includes the:
- medicinal ingredient(s)
- year and month the submission was accepted into review
- therapeutic area populated with the World Health Organization Anatomical Therapeutic Chemical code
For submissions accepted into review on or after October 1, 2018, the following information will be added to the lists of submissions under review (for all other submissions the information is listed as 'not available'):
- company (sponsor) name
- 'class' of the submission
The submission 'class' includes whether the submission is for a new active substance or a biosimilar, if it is being reviewed as per a formal expedited process, if review is taking place as part of an aligned process with a health technology assessment organization, and more. More information can be found on the Submission 'Class' web page.
Lists of submissions completed
Each entry for each submission on the lists of submissions completed includes the:
- medicinal ingredient(s)
- year and month the submission was accepted into review
- therapeutic area populated with the World Health Organization Anatomical Therapeutic Chemical code
- year and month the submission concluded
- hyperlink to the regulatory decision summary or summary of cancellation
Decisions
Submissions are added to the submissions under review list after they have been accepted into review. They remain on this list through interim negative decisions and various administrative and/or regulatory holds. For more information about the submission process and review targets, refer to the Management of Drug Submissions and Applications Guidance.
A submission is removed from the submissions under review list and added to the list of submissions completed when:
- the submission is cancelled or
- a final decision is made
You can see if a submission has been approved in the Notice of Compliance Database.
Information about decisions (positive or negative) and cancellations can be found in the Regulatory Decision Summary documents. If applicable, a more detailed explanation is available in a Summary Basis of Decision document. These documents can be found using the search tools in the Drug and Health Product Portal.
External consultations
Several external consultations have been held throughout the evolution of the SUR List initiative. In 2017, an external consultation was held on five transparency proposals for prescription drugs. This report provides a summary of the consultation results.
Contact us
Questions can be sent to us by email: opprs.enquiries-enquetes.bprse@hc-sc.gc.ca.
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