Health Canada takes action to prioritize generic drug submissions: Notice
September 1, 2026
Our file number: 26-105134 - 755
On this page
Background
Health Canada reviews generic drug submissions to ensure they meet the requirements set out in the Food and Drugs Act and the Food and Drug Regulations. Our performance standards and guidance outline expectations and timelines for the generic drug review process:
Generic drugs are an important part of Canada's health care system, helping support reasonable access to safe and effective drugs for people living in Canada. They must meet our regulatory requirements for safety, efficacy and quality before they can be sold in Canada.
What we’re doing
High volumes and more complex generic drug submissions have been putting pressure on the review process. As a result, Health Canada is currently not meeting our performance standards for the review of some submissions.
To address these challenges, we’re prioritizing the review of generic drug 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
This includes:
- generic drug submissions that can meaningfully contribute to addressing potential harms associated with drug shortages
- non-authorized generic submissions where there’s no authorized generic version of the drug in Canada
Prioritization refers to the order in which eligible submissions are reviewed first. It doesn’t affect the scientific review, regulatory requirements, evidentiary standards or decision-making once a review has begun. It also doesn’t guarantee a generic drug submission will be authorized.
Supporting a stronger drug supply in Canada
Strengthening Canada's domestic pharmaceutical manufacturing capacity may help enhance our country’s supply chain and minimize supply disruptions.
We’re consulting on a pilot to prioritize certain generic drug submissions involving domestic manufacturing in the regulatory review process. The proposed pilot would not create a separate approval pathway or lower the regulatory requirements that a drug must meet before it can be sold in Canada.
The feedback we receive from the consultation will help us refine our approach and design and implement the pilot.
Find information about the pilot and consultation process:
Learn more:
Contact us
If you have questions, email the Bureau of Pharmaceutical Sciences in the Health Products and Food Branch: BPS_enquiries@hc-sc.gc.ca.