Health Canada Grants Access to Rifapentine: A Milestone for Tuberculosis Prevention in Canada
OTTAWA, MARCH 23, 2026 – Stop TB Canada welcomes Health Canada’s decision to grant regulatory approval for rifapentine, a key medication used to prevent tuberculosis (TB). This decision marks an important step toward expanding access to shorter, more effective preventive treatment and bringing Canada closer to eliminating this serious disease that disproportionately impacts Indigenous and newcomer communities.
“Rifapentine is a cornerstone of TB prevention, yet it remains out of reach for many in Canada. When we fail to provide access to the best available tools, we are failing people at risk of TB — and falling behind global standards. This is a solvable problem, and it’s time Canada acted with urgency.”
Rifapentine is recommended as a first-line option in the Canadian Tuberculosis Standards and by international health organizations, including the World Health Organization. The recommended 3HP regimen (consisting of 3 months of weekly rifapentine and isoniazid) has higher completion rates and lower toxicity than older therapies that carry a greater risk of liver damage. Rifapentine can significantly shorten both the length of treatment and the number of doses needed, and is key in preventing severe forms of the disease that can otherwise need treatment for up to 12 months and is associated with risks of disability and even death.
Despite these recommendations, rifapentine has historically been difficult to access in Canada, stemming largely from the fact no company had applied for Health Canada approval. Without a marketed product in Canada, healthcare providers faced complex procurement processes that caused delays and administrative burdens.
In recent years, the drug had to be imported through the federal Access to Drugs in Exceptional Circumstances mechanism, an onerous, time-consuming, and unreliable process. This created a gap between what clinical guidelines recommend and what providers could realistically access, leaving people affected by TB in the lurch. Stop TB Canada’s 2025 report Access to Essential Tuberculosis Medicines in Canada documented further and widespread barriers to access, delayed care, worsening outcomes, and undermining Canada’s ability to prevent TB in the first place.
Limited access has been particularly challenging in regions such as Nunavut, where the burden of TB is high and shorter preventive treatments are essential to delivering effective care in remote settings. Approval for market access of the drug is a crucial resolution to these longstanding challenges.
“We welcome the news that rifapentine has received market authorization in Canada. This will reduce the barriers associated with exceptional regulatory pathways to obtain this essential medication, especially for rural, remote, isolated and Indigenous communities. This new drug submission reflects the joint advocacy efforts from Indigenous leadership, tuberculosis (TB) providers, provincial and territorial TB programs, and federal departments, marking an important step forward in our shared work toward eliminating TB in Canada.”
“As an early investor in the expansion, quality, and affordability of rifapentine-based TB treatment regimens globally, Unitaid warmly welcomes Canada’s approval of rifapentine. Rifapentine-based regimens offer shorter treatment with fewer side effects and better adherence. Health Canada’s approval not only strengthens equitable access for people in Canada but could also help pave the way for broader access in other countries.”
The formal approval of rifapentine as a fully licensed medication in Canada follows years of advocacy by communities, civil society organizations such as Stop TB Canada, researchers, and global health partners working to expand access to shorter, safer, and more effective treatments. International initiatives supported by organizations such as the Global Drug Facility and Unitaid have helped scale up access worldwide, even as many high-income countries, including Canada, have struggled to make these medicines available domestically.
“We’ve known for over two decades that rifapentine-based preventive treatment works really well to prevent this very serious disease, tuberculosis. But until now Canadians haven’t had good access to it. It’s fantastic for patients to have more options for safe, short, effective TB prevention.”
Stop TB Canada understands that Macleods Pharmaceuticals, the manufacturer of the approved product, is positioned to supply rifapentine in Canada. We call on Macleods and Health Canada to move quickly to ensure rifapentine reaches the Canadian market and that a reliable supply is available so patients and clinicians can fully benefit from this long-awaited advance.
About Tuberculosis
Tuberculosis (TB) is a preventable and curable infectious disease caused by Mycobacterium tuberculosis, primarily affecting the lungs. TB remains the world’s leading infectious disease killer, claiming more than 1.2 million lives each year. In Canada, TB continues to disproportionately affect Indigenous communities and people born outside the country.
About Stop TB Canada
Stop TB Canada is a national network of healthcare professionals, researchers, advocates, and community leaders working to raise awareness, mobilize communities, and build political will to end tuberculosis in Canada and globally.
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