Submissions Under Review

Access the list of certain drug submissions currently under review. The submissions under review list is being implemented in a phased approach.

These submissions include new drug submissions (NDSs) containing new active substances, pharmaceuticals and biologics with an active ingredient not approved in Canada. This applies to submissions whose review started on or after April 1, 2015.

Certain submissions are also on the list if they were accepted into review on or after May 1, 2016. These submissions are:

  • NDSs
  • supplemental new drug submissions (SNDSs) for new uses

The entry for each submission includes its medicinal ingredient(s) and therapeutic area. The list is updated monthly.

The submissions under review list aims to enhance the transparency of our review processes. The list will help:

  • Canadians know whether a substance has been accepted for review in Canada
  • support Canadians in making better decisions about their health


A substance is removed from these lists:

  • once a final decision is made and the submission is no longer under review
  • if the submission is cancelled

You can see if a submission has been approved in the Notice of Compliance Database.

You can find an explanation of the decision (positive or negative) or cancellation in the Regulatory Decision Summary (RDS). If applicable, a more detailed explanation is also contained in a Summary Basis of Decision document.

The RDS will be prepared and posted after a submission is removed from the list.

External Consultation Report 2016

The purpose of this report is to provide a summary of the results of the on-line questionnaire. The subject of the questionnaire was health product transparency initiatives.

Submissions under review list: new drug submissions
Medicinal Ingredient(s) Therapeutic Area
Alectinib Antineoplastic agents
Alvimopan Drugs for constipation
Antihemophilic factor (recombinant), pegylated Antihemorrhagics
Atezolizumab Antineoplastic agents
Baricitinib Antiinflammatory and antirheumatic products
Botulinum antitoxin serotypes A, B, C, D, E, F, G Immune sera and immunoglobulins
Brexpiprazole Psycholeptics
Brodalumab Immunosuppressants
Daclizumab Immunosuppressants
Dermatophagoides farinae extract, dermatophagoides pteronyssinus extract Allergens
Edoxaban Antithrombotic agents
Eliglustat tartrate Other alimentary tract and metabolism products
Eluxadoline Drugs for functional gastrointestinal disorders
Etanercept Immunosuppressants
Ferric derisomaltose Antianemic preparations
Fibrinogen (human) Antihemorrhagics
Flibanserin Other gynecologicals
Florbetaben (18F) Diagnostic radiopharmaceuticals
Follitropin delta Sex hormones and modulators of the genital system
Gadoteric acid Contrast media
Iron dextran Antianemic preparations
Lixisenatide Drugs used in diabetes
Lonoctocog alfa Antihemorrhagics
Mercaptamine bitartrate Other alimentary tract and metabolism products
Naloxone hydrochloride All other therapeutic products
Necitumumab Antineoplastic agents
Neisseria meningitidis group B recombinant lipidated protein 2086 subfamilies A, B Vaccines
Nitisinone Other alimentary tract and metabolism products
Nitisinone Other alimentary tract and metabolism products
Nitisinone Other alimentary tract and metabolism products
Ozenoxacin Antibiotics and chemotherapy for dermatological use
Pegaspargase Antineoplastic agents
Peramivir Antivirals for systemic use
Propiverine hydrochloride Urologicals
Sarilumab Immunosuppressants
Tenofovir alafenamide hemifumarate Antivirals for systemic use
Venetoclax Antineoplastic agents
Vernakalant hydrochloride Cardiac therapy
Von Willebrand factor (human) Antihemorrhagics
Submissions under review list: supplemental new drug submissions for new uses
Medicinal Ingredient(s) Therapeutic Area
Anakinra Immunosuppressants
Canagliflozin Drugs used in diabetes
Canakinumab Immunosuppressants
Cobicistat, elvitegravir, emtricitabine, tenofovir alafenamide hemifumarate Antivirals for systemic use
Eltrombopag olamine Antihemorrhagics
Empagliflozin Drugs used in diabetes
Erlotinib hydrochloride Antineoplastic agents
Etanercept Immunosuppressants
Lacosamide Antiepileptics
Leuprolide acetate Endocrine therapy
Linagliptin Drugs used in diabetes
Linagliptin, metformin hydrochloride Drugs used in diabetes
Liraglutide Drugs used in diabetes
Nadroparin calcium Antithrombotic agents
Omalizumab Drugs for obstructive airway diseases
Ombitasvir, paritaprevir, ritonavir Antivirals for systemic use
Palbociclib Antineoplastic agents
Panitumumab Antineoplastic agents
Rufinamide Antiepileptics

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