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:
- 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 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.
|Medicinal Ingredient(s)||Therapeutic Area|
|Alvimopan||Drugs for constipation|
|Antihemophilic factor (recombinant), pegylated||Antihemorrhagics|
|Bilastine||Antihistamines for systemic use|
|Botulinum antitoxin serotypes A, B, C, D, E, F, G||Immune sera and immunoglobulins|
|Eliglustat tartrate||Other alimentary tract and metabolism products|
|Eluxadoline||Drugs for functional gastrointestinal disorders|
|Gadoteric acid||Contrast media|
|Idarucizumab||All other therapeutic products|
|Ixazomib citrate||Antineoplastic agents|
|Mercaptamine bitartrate||Other alimentary tract and metabolism products|
|Naloxone hydrochloride||All other therapeutic products|
|Nitisinone||Other alimentary tract and metabolism products|
|Peramivir||Antivirals for systemic use|
|Rupatadine fumarate||Antihistamines for systemic use|
|Sofosbuvir, velpatasvir||Antivirals for systemic use|
If you have further questions, please email us at OPPRS_enquiries@hc-sc.gc.ca.
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