Health Canada seeks feedback on a proposed pilot approach to prioritize certain generic drug submissions involving domestic manufacturing within the regulatory review queue: Notice
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Purpose of the notice
The purpose of this notice is to seek feedback on a proposed pilot approach to prioritize certain generic drug submissions involving domestic manufacturing within the regulatory review queue. This approach aims to help prevent and mitigate potential supply disruptions for people in Canada.
The pilot will assess whether including domestic manufacturing as one of several review-sequencing factors, can improve the predictability of when qualifying submissions are taken up for review in a high-volume submission environment.
Background
Health Canada reviews drug submissions in accordance with the Food and Drugs Act and the Food and Drug Regulations. Established performance standards and guidance support this process and set expectations for screening and scientific review timelines.
In light of increasing submission volumes, Health Canada is examining opportunities to enhance predictability and transparency in its workload management practices. This includes developing principles to guide submission review sequencing, while ensuring that health and safety outcomes for people in Canada remains paramount.
To help inform this work, Health Canada is proposing a targeted pilot in the generic drug space. It will assess the feasibility and impact of considering domestic manufacturing as an additional review-sequencing factor, with the objective of helping prevent and mitigate harmful interruptions to Canada’s drug supply.
Canada’s pharmaceutical supply relies on both domestic manufacturing and international supply chains. In many drug categories, including generics, Canada continues to rely heavily on global manufacturing networks. This reliance can increase exposure to supply disruptions and reduce the health system’s ability to respond quickly to changing supply dynamics, raising the risk of negative health impacts on people in Canada.
Proposed pilot approach
Health Canada is seeking feedback on a targeted, time-limited pilot to prioritize certain generic drug submissions involving domestic manufacturing within the regulatory review queue. The pilot will assess whether this approach can improve the predictability of when qualifying submissions are taken up for review.
Prioritization refers to the order in which eligible submissions are selected for review within the review queue. It does not affect the scientific review, regulatory requirements, evidentiary standards or decision-making once a review has begun.
The proposed approach would apply only to new submissions received after the pilot is implemented. Any improvement in timeline predictability would result from the earlier initiation of reviews for qualifying submissions, rather than from changes to review standards, performance targets, or regulatory outcomes.
The proposed pilot would assess the introduction of domestic manufacturing as an additional factor in sequencing of submissions within the review queue, to be applied after considering other urgent health and safety factors.
The pilot constitutes a workload management measure only, affecting the order in which submissions are selected for review within the existing operational workflow. It does not affect filing dates, create a new regulatory pathway for drug approval, alter evidentiary requirements or guarantee earlier authorization decisions.
The proposed pilot represents one targeted, interim action within a broader set of measures under consideration across government to support and strengthen Canada's long-term supply security.
Scope
The proposed pilot would apply to certain generic drug submissions, specifically:
- abbreviated new drug submissions (ANDS)
- supplemental abbreviated new drug submissions (SANDS)
Eligibility criteria
Eligibility would be determined at the submission level, based on whether primary drug manufacturing activities occur in Canada as part of the submission.
Sponsors would be required to attest in their cover letter, and include in the submission documents, that their submission involves primary drug manufacturing activities in Canada.
Primary manufacturing includes the core production steps involved in the manufacture of the finished drug product or the drug substance (active pharmaceutical ingredient).
Activities limited to testing, packaging or labelling would not be considered primary manufacturing for the purposes of this pilot and would not qualify for eligibility.
Seeking feedback
The publication of this notice initiates a 60-day public comment period.
Visit the consultation page to learn how you can participate.