Generic submissions under review
How to access a list of generic drug submissions currently under review.
On this page
- About the Generic Submissions Under Review (GSUR) List
- Finding information on the list
- Other lists of submissions under review
- View the list
About the Generic Submissions Under Review (GSUR) List
The Generic Submissions Under Review (GSUR) List helps to make our review processes more transparent. The list will help Canadians understand if generic versions of brand name drugs are currently under review in Canada.
The GSUR List was announced as part of Phase III of the Submissions Under Review (SUR) List initiative.
The GSUR List includes abbreviated new drug submissions (ANDSs) accepted into review on or after October 1, 2018.
Finding information on the list
The GSUR List entries each include the:
- medicinal ingredient(s)
- therapeutic area populated with the World Health Organization Anatomical Therapeutic Chemical code
- number of ANDSs under review with Health Canada that month
The list is updated monthly.
The number of ANDSs under review with Health Canada in any given month changes depending on
- ANDSs that are newly accepted for review
- ANDSs that are cancelled by the sponsor (company)
- Final decisions that are made on ANDSs (positive or negative)
You can see if a submission has been approved in the Notice of Compliance Database.
Health Canada announced in August 2018 that it will publish regulatory decision summaries for final positive and negative decisions for certain prescription generic drug submissions that might be of interest to stakeholders. These can be found using the Regulatory Decision Summary search tool in the Drug and Health Product Register.
Access to generic drugs
Many factors affect Canadians' access to generic drugs. For more information about generic drug products and submissions, please see the Fact Sheet on Access to Generic Drugs in Canada.
Health Canada is now seeking feedback on the possible impacts and uses to stakeholders of adding sponsor (company) names to the Generic Submissions Under Review List.
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.
An earlier external consultation was held in 2016 about health product transparency initiatives. The purpose of this report is to provide a summary of the results of the on-line questionnaire.
Other lists of submissions under review
The Submissions Under Review (SUR) Lists include new drug submissions and supplemental new drug submissions for new uses. Click here for details and to access the Drug and health products submissions under review lists.
View the list
You can view the generic submissions under review list any time.
|Medicinal Ingredient(s)||Therapeutic Area||Number of submissions under review|
|Amoxicillin trihydrate||Antibacterials for systemic use||1|
|Arsenic trioxide||Antineoplastic agents||1|
|Bendamustine hydrochloride||Antineoplastic agents||3|
|Budesonide||Drugs for obstructive airway diseases||1|
|Carbidopa, entacapone, levodopa||Anti-parkinson drugs||1|
|Cephalexin monohydrate||Antibacterials for systemic use||1|
|Dabigatran etexilate||Antithrombotic agents||1|
|Efavirenz, emtricitabine, tenofovir disoproxil fumarate||Antivirals for systemic use||1|
|Emtricitabine, tenofovir disoproxil fumarate||Antivirals for systemic use||1|
|Ertapenem sodium||Antibacterials for systemic use||1|
|Fampridine||Other nervous system drugs||1|
|Fluticasone propionate, salmeterol xinafoate||Drugs for obstructive airway diseases||1|
|Lamivudine, zidovudine||Antivirals for systemic use||1|
|Liothyronine sodium||Thyroid therapy||1|
|Metoclopramide hydrochloride||Drugs for functional gastrointestinal disorders||1|
|Ondansetron||Antiemetics and antinauseants||1|
|Oseltamivir phosphate||Antivirals for systemic use||2|
|Pyridostigmine bromide||Other nervous system drugs||1|
|Rasagiline mesylate||Anti-parkinson drugs||1|
|Rosuvastatin calcium||Lipid modifying agents||1|
|Trandolapril||Agents acting on the renin-angiotensin system||1|
|Vancomycin hydrochloride||Antibacterials for systemic use||1|
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