Health Canada revises approach for granting extensions to responses to notices of deficiency and non-compliance for generic drug submissions: Notice
September 1, 2026
Our file number: 26-105134 - 755
On this page
Background
Health Canada is returning to a more structured approach on how we grant extensions to responses to notices of deficiency (NOD) and notices of non-compliance (NON) for generic drug submissions. Under this revised approach, we will limit sponsors to 1 extension request per notice, for a maximum of 90 days.
This more structured approach to managing extension requests is part of our broader efforts to:
- address workload pressures and
- reduce the backlog of generic drug submissions
This change will:
- support greater regulatory efficiency and predictability
- align review timelines with established performance standards and
- help advance the timely review of generic drug submissions for the benefit of people in Canada
Revised process
If you’re a sponsor of a generic drug submission, you’ll have an initial 90 days to respond to an NOD or NON according to the standard process. You may request a one-time extension of up to 90 days, for a total response period of 180 days. If you can’t provide a complete response within this period, you can cancel the submission. Otherwise, we may issue an NOD-withdrawal (NOD-W) or NON-withdrawal (NON-W), as applicable.
You may refile the submission when you can provide complete information to us.
For more information on submissions, performance standards and refiling requirements, consult:
Learn more:
Scope
This notice applies to:
- abbreviated new drug submissions (ANDS)
- supplemental abbreviated new drug submissions (SANDS)
- applications for drug identification numbers (DINs) and
- all extension requests received as of the date of this notice
We’ll review and approve extension requests on a case-by-case basis.
We encourage you to provide complete, high-quality responses and to engage with us early if you anticipate challenges in meeting established timelines. This will help us review your submission more efficiently and resolve any issues.
Contact us
If you have questions, email the Bureau of Pharmaceutical Sciences in the Health Products and Food Branch: BPS_enquiries@hc-sc.gc.ca.