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.
| 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 |
| 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.