Policy Statement: Reconsideration of decisions for priority review status and advance consideration of Notice of Compliance with conditions (NOC/c)
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Background
Health Canada offers drug submission sponsors two options to seek to obtain abbreviated timelines for the scientific review of human drug submissions, namely by requesting:
- priority review status or
- advance consideration for a Notice of Compliance (NOC) under the Notice of Compliance with conditions (AC-NOC/c) guidance
When approved by Health Canada, qualifying submissions have shortened scientific review timelines of:
- 180 days for priority review
- 200 days for AC-NOC/c
The shortened review timelines aim to facilitate the accelerated review of drugs meeting specific criteria for serious, life-threatening or severely debilitating diseases or conditions.
In December 2025, Health Canada launched a consultation on a proposal to no longer consider requests for reconsideration of rejected requests for priority review status or advance consideration under the NOC/c guidance. After giving careful consideration to feedback received from stakeholders, Health Canada has elected to proceed with the proposed policy change. This will foster the responsible use of the department’s resources and deliver meaningful outcomes and value for people in Canada.
Scope and Purpose
Effective April 22, 2026, Health Canada will no longer consider requests for reconsideration for these types of decisions related to human drug submissions:
- Rejection of a Priority Review Request under the Priority Review Policy
- Rejection of a Request for Advance Consideration under the Notice of Compliance with Conditions Policy (AC-NOC/c)
Requests for priority review status or AC-NOC/c submitted before April 22, 2026, that are rejected would still be eligible for a request for reconsideration.
The reconsideration process requires a significant time investment by Health Canada. It involves evaluators revisiting a Clinical Assessment Package decision for each priority review reconsideration request. This diverts resources from the timely review of other drug submissions. Removing this option will allow Health Canada to:
- allocate medical, clinical and regulatory resources more efficiently
- support a more focused and more efficient regulatory review process
Considerations for sponsors
Sponsors dissatisfied with a decision by Health Canada regarding a priority review or AC-NOC/c request may still file a second request with new information 60 days after the date of the original request. This is considered more efficient and less time-consuming than the formal reconsideration process, while still providing sponsors with opportunities to resubmit.