Health Canada is encouraging the introduction of new drugs (therapies, treatments, and medicines) to Canada by modernising its regulatory review process.
This is being done in a number of ways as follows:
Pharmaceutical and Life Sciences Task Force
- Together with Innovation, Science and Economic Development, Health Canada set up a Pharmaceutical and Life Sciences Task Force in early 2026.
- Senior leaders and experts in the pharmaceutical and life sciences sector made up the task force.
- They advised on innovative, made-in-Canada ways to make us more competitive and make drugs more available.
Ministerial Reliance Order
- Health Canada introduced a Ministerial Reliance Order which allows the department to review certain parts of a drug submission faster by using decisions or documents produced by other select foreign regulators.
- This approach maintains Canada’s requirements for safety, efficacy and quality, while reducing unnecessary duplication.
Modernising the regulations for clinical trials
- Clinical trials are held to explore drugs that have the potential to improve people’s lives.
- Health Canada is modernising the regulations for clinical trials so that people in all parts of Canada can take part in a broader range of clinical trials.
- Streamlining the requirements for clinical trials also benefits drug manufacturers and researchers.
Review of regulatory processes
Health Canada reviewed its regulatory processes to find ways that it could could:
- remove outdated or overly complicated rules and processes
- reduce duplication and overlap with provinces and territories
- streamline how it delivers regulatory decisions
Looking Ahead
Health Canada’s drug review standards are high and its timelines for approving new drugs are among the fastest in the world, particularly for those under priority review.
It wants to:
- maintain its global standing.
- keep improving our review process to meet the growing demand for new drugs.
To this end, it has established 6 strategic priorities which will help to:
- meet the growing demand for new drugs
- make its regulatory process even more efficient
- speed up access to innovative drugs for people in Canada
- develop and expand the use of modern regulatory tools
The 6 strategic priorities are:
1. Encouraging manufacturers to file early to help speed up access to new drugs
Manufacturers are being encouraged to file submissions in Canada earlier, in keeping with other world-leading drug regulators.
- Filing sooner will mean that a drug might make it to the Canadian market in a faster time frame.
- Filing early means that patients may not have to wait as long to access a life-saving drug.
As well as encouraging manufacturers to file earlier, Health Canada is promoting:
- international work-sharing through the Access Consortium
- concurrent reviews of cancer drug submissions through Project Orbis
2. Maintaining drug approval times for priority reviews
Health Canada grants priority review status to eligible new drug submissions for human use.
- Its target for reviewing and approving priority drugs for patients who need them most is around 180 days.
- It has one of the fastest approval times for priority reviews.
- As an example, in 2024, its median time for priority reviews was 223 days, ranking first among international regulators.
3. Expanding use of fast, collaborative pathways to bring new drugs to Canada sooner
Health Canada is expanding the use of fast, collaborative review processes such as priority reviews, international work-sharing, and reliance.
- Its goal is for 40% of new drug submissions to be reviewed through an accelerated or collaborative process.
- Fast-tracking will help get safe and effective drugs to Canadians more quickly.
4. Strengthening capacity to keep pace with global leaders
Health Canada is investing in its regulatory system to reduce backlogs, improve timelines and keep pace with other top international regulators.
Investments to increase its regulatory capacity will:
- speed up review times
- provide more consistent and predictable timelines for manufacturers
- eliminate existing backlogs and prevent future backlogs
With these investments, Health Canada will continue to be an international leader in drug regulation.
5. Making Canada a clinical trials and innovation powerhouse
Health Canada wants to make Canada a top destination for clinical trials and drug innovation. It is working to attract more clinical trials and drug submissions to Canada so patients can access new drugs earlier.
6. Reinforcing Canada’s role as a trusted and reliable global regulator
Canada is recognized worldwide for our strong, science-based decisions. Health Canada continues to lead and collaborate internationally to protect and improve health.
Maintaining Health Canada as a world-class regulator will uphold national and global trust in the safety and quality of drugs sold in Canada. It will also reinforce the decisions Health Canada makes as a regulator.
Source: Health Canada