Improving access to drugs
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Why we’re improving access to drugs
Health Canada is encouraging the introduction of new drugs (therapies, treatments, and medicines) to Canada by modernizing its regulatory review process.
It will also strengthen Canada’s economy by making us more competitive and productive.
Canadians will have better access to the drugs they need while maintaining high standards of safety, efficacy and quality.
This work builds on the Government of Canada’s red tape review. The goal is to create a regulatory system that:
- is risk-based
- supports domestic industry
- aligns with comparable international regulators
- is easier for people in Canada and businesses to navigate
What we’re doing to improve access to drugs
We’re improving access to drugs in a number of ways.
Together with Innovation, Science and Economic Development, we 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.
We 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.
Clinical trials are held to explore drugs that have the potential to improve people’s lives. We are modernizing 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.
We reviewed our regulatory processes to find ways we could:
- remove outdated or overly complicated rules and processes
- reduce duplication and overlap with provinces and territories
- streamline how we deliver regulatory decisions
Learn more:
- Pharmaceutical and Life Sciences Task Force
- Ministerial Reliance Order
- Modernizing clinical trial regulations
- Streamlining requirements by cutting red tape
Looking ahead
Our drug review standards are high and our timelines for approving new drugs are among the fastest in the world, particularly for those under priority review.
We want to maintain our global standing. We also want to keep improving our review process to meet the growing demand for new drugs.
To this end, we have established 6 strategic priorities. These priorities will help us:
- meet the growing demand for new drugs
- make our regulatory process even more efficient
- speed up access to innovative drugs for people in Canada
- develop and expand the use of modern regulatory tools
1. Encouraging manufacturers to file early to help speed up access to new drugs
We’re encouraging manufacturers 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, we’re 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. Our target for reviewing and approving priority drugs for patients who need them most is around 180 days.
We have one of the fastest approval times for priority reviews. As an example, in 2024, our 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
We’re expanding the use of fast, collaborative review processes such as priority reviews, international work-sharing, and reliance. Our 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
We’re investing in our regulatory system to reduce backlogs, improve timelines and keep pace with other top international regulators.
Investments to increase our 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
We want to make Canada a top destination for clinical trials and drug innovation. We’re 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. We continue 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 we make as a regulator.
Learn more about what we’re doing:
- Health Canada opens formal consultations on red tape reduction initiatives to improve access to drugs
- Remarks for the Honourable Marjorie Michel, Minister of Health – Health and economic prosperity: Opportunities for Canada
- Remarks for the Honourable Marjorie Michel, Minister of Health – Canada’s new approach on drugs to save lives, reduce cost and build the economy
For more information: