Health Canada is not currently meeting its performance standards for the review of some generic drug submissions. On September 1, 2026, Health Canada launched a new webpage, Improving how we review generic drugs, and released three notices on proposed actions to address the backlog of generic drug submissions under review.
Prioritizing certain generic drug submissions
Health Canada will be prioritizing the review of those generic submissions that will help:
- give greater access to medicines in Canada;
- prevent and minimize disruptions to Canada’s drug supply; and
- sustain the generic drug review system in the long term.
Such submissions include:
- generic drug submissions that can meaningfully contribute to addressing potential harms associated with drug shortages; and
- non-authorized generic submissions where there’s no authorized generic version of the drug in Canada.
The Health Canada notice also refers to a proposed pilot project that would prioritize certain generic drug submissions involving domestic manufacturing within the regulatory review queue. As previously reported, the pilot was under consultation until September 12, 2026.
The notice does not address how Health Canada will decide which of the above prioritized categories, or submissions within the category, will be reviewed first.
Request for additional information for backlog submissions in review 2
Review 2 is the stage of review after a sponsor has responded to a notice of non-compliance (NON). The current Guidance document on management of drug submissions and applications does not contemplate additional information beyond the response to a NON as part of Review 2.
Under the new approach, once Health Canada has reviewed the sponsor’s response to the NON, it will request additional safety, efficacy or quality information or material if it deems it necessary. Health Canada will only accept information or material that is directly related to the additional request and may issue a notice of non-compliance-withdrawal (NON-W) if the information provided is insufficient.
A sponsor in Review 2 cannot make major changes (such as addition of a new indication or new route of administration), which would require the filing of a supplement or new submission.
Revised approach to granting extensions
A sponsor that has received a notice of deficiency (NOD) or NON has an initial 90 days to respond according to the standard process. According to the Notice, Health Canada is returning to a more structured approach to granting extensions to responses to NODs or NONs. The sponsor may only request a one-time extension of up to 90 days per notice, for a total response period of 180 days. If a complete response cannot be provided within this extended period, the sponsor can cancel the submission. Otherwise, Health Canada may issue a NOD-withdrawal or NON-W.
Should you have any questions, please do not hesitate to contact a member of the Life Sciences Regulatory & Compliance Group or the Pharmaceutical Litigation Group.
The preceding is intended as a timely update on Canadian intellectual property and life sciences regulatory law. The content is informational only and does not constitute legal or professional advice. To obtain such advice, please communicate with our offices directly.