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

Decisions

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.

Submissions under review list: new drug submissions
Medicinal Ingredient(s) Therapeutic Area
Alectinib Antineoplastic agents
Alvimopan Drugs for constipation
Antihemophilic factor (recombinant), pegylated Antihemorrhagics
Baricitinib Antiinflammatory and antirheumatic products
Bepotastine besilate Ophthalmologicals
Botulinum antitoxin serotypes A, B, C, D, E, F, G Immune sera and immunoglobulins
Brexpiprazole Psycholeptics
Daclizumab Immunosuppressants
Daratumumab Antineoplastic agents
Edoxaban Antithrombotic agents
Eliglustat tartrate Other alimentary tract and metabolism products
Eluxadoline Drugs for functional gastrointestinal disorders
Etanercept Immunosuppressants
Flibanserin Other gynecologicals
Florbetaben (18F) Diagnostic radiopharmaceuticals
Gadoteric acid Contrast media
Iron dextran Antianemic preparations
Ixazomib citrate Antineoplastic agents
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
Nitisinone Other alimentary tract and metabolism products
Nitisinone Other alimentary tract and metabolism products
Osimertinib Antineoplastic agents
Panobinostat Antineoplastic agents
Pegaspargase Antineoplastic agents
Peramivir Antivirals for systemic use
Propiverine hydrochloride Urologicals
Reslizumab Immunosuppressants
Rupatadine fumarate Antihistamines for systemic use
Sarilumab Immunosuppressants
Sofosbuvir, velpatasvir Antivirals for systemic use
Venetoclax Antineoplastic agents
Vernakalant hydrochloride Cardiac therapy
 
Submissions under review list: supplemental new drug submissions for new uses
Medicinal Ingredient(s) Therapeutic Area
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
Omalizumab Drugs for obstructive airway diseases
Panitumumab Antineoplastic agents
Rufinamide Antiepileptics

If you have further questions, please email us at OPPRS_enquiries@hc-sc.gc.ca.

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