Drug and health product submissions under review (SUR)

How to access lists of drug submissions currently under review, and lists of certain drug submissions formerly under review.

Submissions under review related to the COVID-19 pandemic

The Submissions Under Review (SUR) Lists include submissions filed under the Food and Drug Regulations for use in relation to the COVID-19 pandemic. These submissions are identified under the submission ‘class’ column. To find these submissions, type “COVID” into the “Filter items” box at the top of the list.

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.

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 currently under review
supplemental new drug submissions currently under review
new drug submissions formerly under review
supplemental new drug submissions formerly under review

All four lists are updated monthly. A substance is moved from the list of submissions currently under review to the list of submissions formerly under review when it reaches a conclusion (it is cancelled, or a final decision is made).

Lists of submissions currently under review

The entry for each submission on the lists of submissions currently under review includes the:

medicinal ingredient(s)
month and year 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 currently under review:

company 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 formerly under review

Each entry for each submission on the lists of submissions formerly under review includes the:

medicinal ingredient(s)
month and year the submission was accepted into review
therapeutic area populated with the World Health Organization Anatomical Therapeutic Chemical code
month and year the submission concluded
hyperlink to the regulatory decision summary or summary of cancellation

Decisions

A substance is removed from the submissions currently under review list and added to the submissions formerly under review list when:

the submission is cancelled or
a final decision is made and the submission is no longer under review

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. If applicable, a more detailed explanation is available in a Summary Basis of Decision document.

External Consultations

Several external consultations have been held as the SUR List initiative has evolved. 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: hc.opprs.enquiries-enquetes.bprse.sc@canada.ca.

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Drug and Health Product Submissions Under Review (SUR)

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