Drug and Health Product Submissions Under Review (SUR): Overview

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

On this page

• About the submissions under review lists
• Finding information on the lists
• Decisions
• External consultations
• Contact us

About the submissions under review lists

The submissions under review (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 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.

Learn more about the Generic Submissions Under Review (GSUR) list.

Finding information on the lists

There are four 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).

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
• submission 'class' (see below)

Lists of submissions completed

Each entry for each submission on the lists of submissions completed includes the:

• medicinal ingredient(s)
• date the submission was accepted into review
• therapeutic area populated with the World Health Organization Anatomical Therapeutic Chemical code
• date the submission concluded
• hyperlink to the regulatory decision summary or summary of cancellation
• submission 'class' (see below)

Submission 'class'

The submission 'class' includes information on whether:

• the submission is for an extraordinary use new drug
• the submission is for a new active substance or a biosimilar
• it is being reviewed as per a formal expedited process (Priority Review Policy or Notice of Compliance with Conditions Guidance)
• it is being reviewed under the Submissions Relying on Third-Party Data Guidance
• the review is taking place as part of an aligned process with a health technology assessment organization
• the drug is for use in relation to COVID-19

For completed submissions only, the 'class' also indicates if the submission was reviewed as part of the Access Consortium or Project Orbis.

Learn more about the Submission 'class'.

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 Guidance on management of drug submissions and applications.

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 at opprs.enquiries-enquetes.bprse@hc-sc.gc.ca.