Proposal to remove reconsideration process from requests for priority review and advance consideration for Notice of Compliance with conditions: Notice
To better serve people in Canada within today's fiscal context, while still protecting health and safety, Health Canada is focusing its efforts and reviewing operations to identify opportunities to maximize resource use. This proposal reflects our commitment to delivering meaningful outcomes and value for Canadians while being responsible stewards of our resources.
Current policy
Under current policy, sponsors can seek to obtain abbreviated timelines for the scientific review of drug submissions by requesting priority review status or advance consideration for a Notice of Compliance (NOC) under the Notice of Compliance with conditions (NOC/c) guidance. When accorded by Health Canada, these result in shortened scientific review timelines of 180 days (priority review) or 200 days (NOC/c). The shortened review timelines aim to facilitate accelerated authorization of drugs meeting specific criteria for serious, life-threatening or severely debilitating diseases or conditions.
Currently, if the initial request is refused, a sponsor may either:
- submit a request for reconsideration in accordance with the Guidance document: Reconsideration of Decisions Issued for Human Drug and Natural Health Product Submissions, or
- file a second request containing new information following a period of 60 days from the date of the original request.
Proposal
Health Canada is inviting feedback on a proposal to no longer consider requests for reconsideration for the following types of decisions:
- 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)
Impacts and benefits
Health Canada has conducted a thorough review of the decisions issued for reconsideration processes in relation to rejected priority review requests. Over the past 10 years, a total of 6% of rejected priority review requests have gone for reconsideration, with a greater proportion of these being related to biologic drugs. Of these requests for reconsideration, only 8% resulted in decisions being amended. No requests for reconsideration of the AC-NOC/c have been received by the Biologic and Radiopharmaceutical Drugs Directorate (BRDD) or the Pharmaceutical Drugs Directorate (PDD). As such, it is expected that sponsors would be minimally affected.
Removing this option would allow Health Canada to allocate medical, clinical and regulatory resources more efficiently. The reconsideration process involves significant time investment by Health Canada and involves evaluators being assigned to revisit a Clinical Assessment Package (CAP) decision for each priority review reconsideration request, thus diverting resources from the timely review of other drug submissions. Eliminating these requests would support a more focused and more efficient regulatory review process, benefitting Health Canada, its stakeholders and ultimately patients.
Sponsors that are dissatisfied with the Health Canada decision about a priority review or AC-NOC/c request may still file a second request or, in some instances, file a submission. This option is considered more efficient and less time-consuming than the formal reconsideration process, while continuing to provide sponsors with opportunities for resubmission. This is due to the fact that timelines for the reconsideration process can at times exceed those of submitting a second request for priority review.
Next steps
It is proposed that this modification to the Guidance document: Reconsideration of Decisions Issued for Human Drug and Natural Health Product Submissions would apply to requests for priority review and AC-NOC/c received by Health Canada on or after April 1, 2026.
Stakeholders are invited to express their views regarding this modification by February 6, 2026. All comments should be sent to: brdd-cppic_brdd-cppci@hc-sc.gc.ca.