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Helping Canadians access safe, effective treatments and medicines faster


July 15, 2026 | Ottawa, Ontario | Health Canada

Canadians expect timely access to safe and effective drugs and medical devices. Health Canada is taking practical steps to modernize and improve the efficiency of its regulatory processes, while maintaining its high standards for safety, efficacy, and quality.

Over the last three months, Health Canada has approved 537 new drugs and medical devices to help Canadians manage and treat a range of health issues. This includes three generic versions of semaglutide, the first G7 country to do so.

In addition, to help bring more medications and treatments to Canada sooner, Health Canada has published a Ministerial Reliance Order. The Order allows the department to review certain parts of drug submissions faster by using decisions or documents produced by select foreign regulators. This approach maintains Canada’s requirements for safety, efficacy and quality, while reducing unnecessary duplication. A more efficient process will also encourage manufacturers to bring products to Canada. The first classes of drugs that will be accepted by Health Canada under the Order include drugs for pediatric use and veterinary drugs.

At the same time, Health Canada is seeking feedback on a proposed approach to prioritize the review of certain generic drug submissions that involve Canadian manufacturing. Supporting Canada’s generic pharmaceutical and life sciences sector will play a key role in enhancing the security of the drug supply and preventing harmful shortages that could negatively impact the health of Canadians.

Complementing Health Canada’s regulatory modernization efforts, the Canadian Institutes of Health Research (CIHR) continues to support health research and clinical trials that generate the evidence needed to evaluate new drugs, medical devices and other health products, helping strengthen Canada’s life sciences ecosystem and improve access to innovative treatments for Canadians.

These initiatives are helping build a more modern and efficient regulatory system—one that supports faster and expanded access to drugs for Canadians, without compromising Canada’s high standards for safety, efficacy and quality.



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Drugs and medical devices authorized, April 1 to June 30, 2026


Backgrounder

July 2026

From April 1 to June 30, 2026, Health Canada approved 15 new drug submissions (8 pharmaceuticals, 7 biologics) and 481 new medical devices, including 22 Class IV medical devices, which present the greatest potential risk. During this period, Health Canada also approved 31 generic drugs and 10 biosimilar drugs.

New and innovator drug approvals
Date Drug Purpose
June 26, 2026 Vimkunya Vaccine for Chikungunya
June 22, 2026 Boey Muscle relaxants
June 15, 2026 Exdensur Drugs for obstructive airway diseases
June 12, 2026 Pimjetmi Antineoplastic agents
June 10, 2026 Lupin-Glugacon Pancreatic hormones
June 3, 2026 Idvynso Antivirals for systemic use
May 29, 2026 Loargys Other alimentary tract and metabolism products
May 15, 2026 Thyconvi Thyroid therapy
May 14, 2026 Iheezo Ophthalmologicals
April 30, 2026 Kisunla Psychoanaleptics
April 16, 2026 Tevimbra Antineoplastic agents
April 10, 2026 Lunsumio SC Antineoplastic agents
April 10, 2026 Vueway Contrast media
April 9, 2026 Yeytuo Antivirals for systemic use
April 9, 2026 neffy Drugs for obstructive airway diseases
New Class IV medical device approvals
Date Medical Device Purpose
June 30, 2026 Visualase V2 MRI-guided laser ablation system Tool for neurosurgery
June 29. 2026 Epic Elite/Epic Supra G3 stented porcine tissue valve and sizers Replacement of heart valve
June 29, 2026 Alinity S CMV IGG qualitative assay Diagnostic and screening test kit for cytomegalovirus
June 24, 2026 SGTi-flex COVID-19 & flu A/B Ag Combo Point of care testing kit for COVID-19 and flu
June 10, 2026 cobas Respiratory flex Test to help in the diagnosis of respiratory infections
June 4, 2026 Seprafilm adhesion barrier For use in surgery to reduce internal organ adhesions
June 3, 2026 Affera ablation system Mapping and treatment of an abnormal heart beat
June 2, 2026 Shockwave intravascular lithotripsy (IVL) system with shockwave C2 aero coronary IVL catheter Treatment of heart disease
May 29, 2026 Jade plus PTA balloon dilatation catheter Treatment of heart disease
May 27, 2026 COVID-19 & Influenza A/B&RSV Antigen Pen Home Test Home testing kit for COVID-19, flu and RSV
May 26, 2026 Procleix Babesia Assay Test kit for screening blood, organ and tissue donors for Babesia
May 26, 2026 iVascular iCover, ballon expandable covered peripheral stent system Treatment of blood vessel diseases
May 26, 2026 cobas Microbial Inactivation Solution Preparation of testing specimens
May 26, 2026 Automated external defibrillator Automated external defibrillator for public use
May 6, 2026 Alinity i Anti-HCV Next Assay Test kit to help in diagnosis and donor screening for Hepatitis C
May 5, 2026 Simplexa COVID-19/flu A/B & RSV direct assay Testing kit to help in diagnosis of COVID-19, flu and RSV infections
May 4, 2026 iStatis Hepatitis B Surface Antigent (HBsAg) Test/iStatis Hepatitis B Surface Antigent (HBsAg) Test Controls Point of care test kit to help in diagnosis of Hepatitis B infections
April 27, 2026 NUVISION ultrasound catheter Imaging of heart or blood vessels
April 24, 2026 Supraflex sirolimus eluting stent system Treatment of heart disease
April 16, 2026 Scoreflex TRIO Balloon Dilatation Catheter Treatment of narrowing in heart arteries to improve blood flow
April 15, 2026 Cobas liat system Testing kit to help in diagnosis of COVID-19, flu and RSV infections
April 1, 2026 Volt PFA catheter, sensor enabled Treatment of heart disease

For more information on these and other drug and medical device approvals, consult:

  • The Drug Product Database, which contains product-specific information on drugs that have been approved for use in Canada such as their availability and product monograph.
  • The Medical Devices Active Licence Listing (MDALL) database, which contains the complete list of all medical devices that have been authorized for sale in Canada.
  • Medical devices in Canada are classified from Class I to Class IV based on the level of risk they pose. Class IV devices represent the highest-risk category and are subject to a rigorous pre-market review by Health Canada to ensure that they meet safety, effectiveness and quality requirements before they can be sold in Canada.



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Canada and Quebec build on partnership to strengthen youth mental health


July 13, 2026 | Montreal, QC | Health Canada

Young people across Canada are struggling with their mental health. Timely access to the right services and supports within their communities can help create lasting and meaningful improvements in the mental health of youth and for their families.

Today, the Honourable Marjorie Michel, Minister of Health, and Lionel Carmant, Quebec’s Minister Responsible for Social Services and the Fight Against Homelessness, announced a new agreement that will provide the Province of Quebec with $70.8 million over four years through the Youth Mental Health Fund.

This investment will help Quebec strengthen the networks of Integrated Youth Services (IYS). It aims to improve equitable access to comprehensive health care—both physical and mental—in order to better meet the needs of young people and promote their well-being. Thanks to this support, more youth facing physical or mental health challenges will be able to access the services they need. Many of these youth, who are often underserved, face disproportionate barriers to accessing high-quality care.

This funding will, among other things, make it possible to expand Quebec’s Aire Ouverte model. Youth will have access to a range of services in one place, including mental health and substance use support, physical and sexual health, youth and family peer support, and social services. Established in 2018, Quebec’s Aire Ouverte IYS model offers comprehensive services, including mental health services, to young people aged 12 to 25 in a free and confidential manner.

The government of Canada, in collaboration with the government of Quebec, remains committed to supporting the mental health of young people everywhere in Canada, providing them with timely access to services and supports in their communities.



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Government of Canada to make announcement in support of youth mental health in Quebec


July 10, 2026, Montréal, QC – The Honourable Marjorie Michel, Minister of Health, and Lionel Carmant, Quebec’s Minister Responsible for Social Services and the Fight Against Homelessness, will hold a news conference to announce mental health care support to more youth in Quebec.

There will be a media availability immediately following the announcement.

Members of the media are invited to participate in the tour for B-Roll footage after the event.

Date
July 13, 2026

Time
11:00 a.m. (ET)

Location

The event will be held in-person at:

Aire Ouverte Montréal-Nord-Lacordaire
12415 Lacordaire Boulevard
Montréal-Nord, QC H1G 4L5

Media may also join by Zoom:
https://hc-sc-gc-ca.zoom.us/j/61223023666
Passcode: 260713

Please indicate your name (first and last) and media outlet when joining the event.

X: @GovCanHealth
Facebook: Healthy Canadians





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Government of Canada approves new technology to support farmers and a more sustainable use of pest management products


June 30, 2026 | Ottawa, Ontario | Health Canada

Aerial application of pest-management products by aircraft presents several challenges. Weather, particularly wind, can cause spray drift and uneven coverage. They also consume large quantities of aviation fuel, increasing operating costs and emissions. Additionally, typical aircraft payloads and spray systems can make precise, low-altitude targeted applications difficult.

By contrast, Remotely Piloted Aircraft Systems or RPAS, commonly known as drones can operate from confined sites, fly lower and slower for greater application precision and reduce fuel use and emissions, making them an easier and more sustainable alternative for many pest-management tasks.

On June 30, 2026, Health Canada introduced a new policy allowing drone technology to be used to apply pesticides that are already approved for conventional aerial application. Agriculture and Agri-Food Canada, Health Canada and industry worked collaboratively to gather evidence to inform the development of this policy decision. This policy removes barriers and gives Canadian farmers another way to protect and grow their crops more efficiently.

Drone technology offers farmers an innovative, precise and more cost-effective tool for pest management. By helping growers reach fields and areas that may be difficult to access using conventional equipment, it can support timely crop protection, reduce operational challenges and help safeguard crop yields.

By adopting this new science policy, Health Canada is addressing the needs of farmers and growers and bringing Canada into alignment competitively with other countries such as Australia and Japan, where drones are already being used for pesticide application. As this technology advances, Health Canada will continue to adapt, using science-based decision-making to support innovation while maintaining strong protections for human health and the environment.



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Canada approves first generic semaglutide for weight loss


June 29, 2026 | Ottawa, Ontario | Health Canada

Today, Health Canada authorized a first generic semaglutide injection for weight loss. Health Canada is currently reviewing six other submissions for generic semaglutide by different companies. The department expects to make regulatory decisions on more of these submissions in the coming weeks and months.

The semaglutide injection submission, known as Svemia, filed by Canadian-based Apotex is a generic version of the brand name drug Wegovy. Health Canada authorized the drug after a thorough review of evidence provided by the company demonstrated that the drug meets Health Canada’s criteria for safety, efficacy and quality for generic drugs. This semaglutide injection is indicated for the once-weekly treatment of patients 12 years and over, as a supplement to a reduced-calorie diet and increased physical activity for chronic weight management.

The generic versions of semaglutide are complex synthetic products that are pharmaceutically equivalent to the brand name biologic drug. Health Canada’s review ensures that differences between these products do not affect the safety, efficacy, or quality of the drug. The availability of generic drugs is expected to have a positive impact in Canada, including potential cost savings for patients and the healthcare system.

As it does with all drugs authorized in Canada, Health Canada will continue to monitor the safety and effectiveness of all generic semaglutide products. Should any unexpected safety or effectiveness concerns arise, Health Canada will take appropriate action to protect the health and safety of Canadians.



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