Improving how we review generic drugs
Learn how we’re addressing the backlog of generic drug submissions and strengthening the review process for generic drugs.
On this page
Taking action to improve the review process
Generic drugs are an important part of Canada’s health care system. Timely regulatory decisions help support reasonable access to safe, effective and high-quality drugs for people living in Canada.
However, Health Canada is facing a backlog of generic drug submissions. We’re receiving far more generic drug submissions, and the submissions themselves are becoming more complex. This has put pressure on our ability to review some of them in a timely fashion. As a result, there are generic submissions remaining in the review process for a long time.
We’re taking action to address the backlog. The changes we’re making will also:
- make the review process more efficient and predictable
- strengthen the long-term sustainability of the review system
What we’re doing
We’re making changes to how we review generic drug submissions. These changes are designed to improve and make the review process more predictable, and reduce the backlog.
For example, we’re:
- increasing our capacity to review submissions
- improving the way we manage and prioritize submissions
- making better and more effective use of available resources
- strengthening the review process to help us manage the growing volume and increased complexity of submissions
These actions will not change the scientific and regulatory requirements that generic drugs must meet before they can be sold in Canada.
We’re also looking at ways we can help prevent and mitigate potential disruptions to the supply of medicines in Canada.
One way is a targeted pilot approach to prioritize certain generic drug submissions involving domestic manufacturing in the regulatory review process. Strengthening our domestic pharmaceutical manufacturing capacity may help enhance our country’s supply chain and minimize supply disruptions.
Learn more about the pilot and the consultation we held:
Read our notices related to generic drug submissions:
- Health Canada takes action to prioritize generic drug submissions
- Health Canada may request additional information for backlog generic submissions in review 2
- Health Canada revises approach for granting extensions to responses to notices of deficiency and non-compliance for generic drug submissions
What this means for you
Improving the review process will help support timely access to generic medicines while continuing to maintain Canada's safety, efficacy and quality standards.
Regulatory review is a key part of the process for getting a generic drug authorized for sale in Canada. Other factors, such as a manufacturer's decision to market the product, manufacturing capacity, distribution and supply, can affect availability.
We’ll continue to update you about our work to improve the generic drug review process as we develop new initiatives.
Contact us
Bureau of Pharmaceutical Sciences
Pharmaceutical Drugs Directorate
Health Products and Food Branch
Health Canada
Email: BPS_enquiries@hc-sc.gc.ca