Policy Statement: Reconsideration of Decisions for Priority Review Status and AC-NOC/c
Summary
Health Canada announces a policy change effective April 22, 2026, eliminating the reconsideration pathway for rejected Priority Review Requests and rejected Requests for Advance Consideration under the Notice of Compliance with Conditions (AC-NOC/c) Policy. Requests for priority review status or AC-NOC/c submitted before April 22, 2026, that are rejected will still be eligible for reconsideration. Sponsors dissatisfied with a decision may file a second request with new information 60 days after the original request date.
Pharmaceutical sponsors should update their regulatory submission strategies to account for the elimination of the reconsideration pathway after April 22, 2026. Sponsors with pending reconsideration requests should confirm their eligibility before the effective date, as rejections of requests submitted before April 22, 2026, are still eligible for reconsideration. The 60-day resubmission option with new information becomes the primary mechanism for addressing rejections — sponsors should ensure any new information is substantive and distinguishable from the original request to avoid a second rejection.
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What changed
Health Canada is removing the formal reconsideration process for rejected Priority Review Requests and AC-NOC/c requests, effective April 22, 2026. The agency states that the reconsideration process requires significant time investment, diverting resources from timely review of other drug submissions. Affected drug submission sponsors who receive a rejection will no longer have the option to formally request reconsideration of that decision after April 22, 2026. The change aims to allow more efficient allocation of medical, clinical, and regulatory resources toward a focused review process.
Drug sponsors seeking to contest a rejection now have a more limited pathway: they may only file a second request with new information 60 days after the date of the original request. Sponsors with pending reconsideration requests submitted before April 22, 2026, should confirm their eligibility while the transitional provision remains in effect. This policy shift is relevant for pharmaceutical companies planning submission timelines for accelerated review under the Priority Review (180-day) or AC-NOC/c (200-day) pathways.
Archived snapshot
Apr 22, 2026GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.
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.
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2026-04-22
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