Submissions Under Review

Access the list of new drug submissions (NDSs) currently under review. These submissions are for drugs 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.

The submissions under review list is being implemented in a phased approach.

Certain submissions will be added to the list if they are 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 this list:

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

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:
Medicinal Ingredient(s) Therapeutic Area
Alectinib Antineoplastic agents
Alvimopan Drugs for constipation
Antihemophilic factor (recombinant), pegylated Antihemorrhagics
Bepotastine besilate Ophthalmologicals
Bilastine Antihistamines for systemic use
Botulinum antitoxin serotypes A, B, C, D, E, F, G Immune sera and immunoglobulins
Brexpiprazole Psycholeptics
Daratumumab Antineoplastic agents
Edoxaban Antithrombotic agents
Eliglustat tartrate Other alimentary tract and metabolism products
Elotuzumab Antineoplastic agents
Eluxadoline Drugs for functional gastrointestinal disorders
Flibanserin Other gynecologicals
Gadoteric acid Contrast media
Idarucizumab All other therapeutic products
Ixazomib citrate Antineoplastic agents
Ixekizumab Immunosuppressants
Lonoctocog alfa Antihemorrhagics
Mercaptamine bitartrate Other alimentary tract and metabolism products
Naloxone hydrochloride All other therapeutic products
Nitisinone Other alimentary tract and metabolism products
Olaparib Antineoplastic agents
Osimertinib Antineoplastic agents
Panobinostat 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

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

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