Mid-year update: Health products approved in 2021
Learn about our work to support Canada's response to COVID-19, the new drugs, medical devices, over-the counter and natural health products that Health Canada approved for sale in Canada, as well as clinical information that was published.
On this page
- Message from the Assistant Deputy Ministers
- Our COVID-19 regulatory response
- Improving access to drugs for human use
- Improving access to over-the-counter (non-prescription) drugs and natural health products
- Improving access to drugs for veterinary use
- Improving access to medical devices
- Publicly released clinical information
- Adverse reactions and incidents
Message from the Assistant Deputy Ministers
We are pleased to provide an update on the drugs, medical devices, over-the-counter (non-prescription) drugs and natural health products approved by Health Canada between January and June 2021.
The regulatory response to COVID-19 has continued to play a key role in our work. This includes the approval of three additional COVID-19 vaccines, along with ongoing and rigorous post-market monitoring of COVID-19-related products.
While these remain extraordinary times, we are committed to working with our partners and stakeholders to provide the products and information Canadians need to stay safe and healthy as we move together toward a post-pandemic future.
Assistant Deputy Minister
Health Products and Food Branch
Associate Assistant Deputy Minister
Health Products and Food Branch
Our COVID-19 regulatory response
As the national regulator of health products, we continue to play a key role in Canada's ongoing response to the COVID-19 pandemic. Since the start of the pandemic, we have leveraged an agile regulatory approach, which has included the introduction of emergency regulatory pathways and measures to support expedited access to needed health products.
Health products: Approvals
Between January and June, we approved:
- 27 clinical trials;
- 3 vaccines;
- 182 hand sanitizers;
- 96 disinfectants; and
- 167 medical devices (25 test kits).
Clinical trials continue to be approved for the study of potential COVID-19 vaccines and treatments.
For example, on April 8, 2021, we authorized an adaptive Platform Treatment Trial for Outpatients with COVID-19 (by the National Institute of Allergy and Infectious Diseases) to evaluate the safety and effectiveness of different drugs in treating COVID-19 in outpatients. This study will test multiple drugs in people who have tested positive for COVID-19 but do not currently need hospitalization. This could help to prevent disease progression to more serious symptoms and complications, and the spread of COVID-19 in the community.
On May 5, 2021, we authorized the MOSAIC Study (Mix and match of the second COVID-19 vaccine dose for Safety and Immunogenicity). This Canadian study is examining the safety and immune response of mixing and matching approved COVID-19 vaccines using various time intervals in adults.
Moreover, Medicago's plant-based Recombinant Coronavirus-Like Particle COVID-19 Vaccine is now in phase III clinical trials. Medicago's COVID-19 vaccine is the first Canadian manufactured vaccine in a phase III trial. It is also unique in that it incorporates a plant-based protein.
Since approving the Pfizer and Moderna COVID-19 vaccines in December 2020, we authorized three other vaccines, i.e., Janssen, AstraZeneca, and the Serum Institute of India's version of the AstraZeneca vaccine, COVISHIELD.
On May 5, 2021, we approved the use of the Pfizer-BioNTech COVID-19 vaccine in children 12 to 15 years of age. This is the first COVID-19 vaccine authorized in Canada for this age group and marks a significant milestone in Canada's fight against the COVID-19 pandemic.
Regulatory review and oversight for these products continues, with updated regulatory and product information added to the COVID-19 vaccines and treatments portal on an ongoing basis.
Self-testing and point-of-care devices
As we continue to adapt to the evolving challenges of the pandemic, the review of self-testing and point-of-care devices (which can be used by trained operators) is being prioritized to support greater access to COVID-19 testing. The first COVID-19 self-testing device was authorized for sale in April 2021. More information on Self-testing and point-of-care devices can be found on the website.
Hand sanitizers and disinfectants
We have also continued efforts in this area in response to COVID-19, by authorizing 182 hand sanitizers and 96 disinfectants between January and June. More information can be found on the website: Hard-surface disinfectants and hand sanitizers (COVID-19).
Monitoring and surveillance
We continue to monitor and assess the safety of all COVID-19-related products, including: those approved for the treatment of COVID-19 infection and those used off-label; authorized vaccines; technical grade ethanol-containing hand sanitizer products; over-the-counter drugs and natural health products used in the context of COVID-19; and medical devices authorized for the diagnosis, treatment, mitigation or prevention of COVID-19.
The data derived from these safety monitoring and surveillance activities has supported Health Canada's scientific and medical staff in collecting and analyzing product safety information (including reports of adverse events), conducting safety assessments, applying risk management measures, and communicating product risks to the public and healthcare professionals.
We continue to work with our international partners, participating in discussions regarding new COVID-19 treatments and vaccines, including the real-world safety and effectiveness of those products. Along with the Public Health Agency of Canada, we are collaborating worldwide on research, taking proactive steps to identify adverse events, and quickly implementing risk-management measures (such as labelling updates and risk communications). For more information on international engagement, visit the website.
Published data and information
We continue to publish regulatory and product information on the Health Canada website and the COVID-19 vaccines and treatments portal to support the high demand for credible scientific data.
Updated authorization requirements
On March 18, 2021, we introduced transition measures to provide a mechanism for COVID-19 products approved under the Interim Order to obtain a Notice of Compliance (NOC) in a timely manner. These transition measures ensure that Canadians have continued and timely access to safe, effective and quality COVID-19 drugs.
Extended regulatory emergency pathways
Finally, the emergency regulatory pathways for clinical trials and medical devices have been extended for another year, and amendments to the Food and Drug Regulations were made to maintain flexibilities for COVID-19-related drugs and vaccines on a longer-term basis.
Improving access to drugs for human use
While we have continued to respond to COVID-19, we also carry on authorizing other products that are vital to the health and well-being of Canadians. Specifically, between January and June, we authorized a number of clinical trials and new drugs, and updated regulations directed at improving available treatment options.
Through the expedited review of single patient clinical trials, Health Canada is contributing to improved access to investigational drugs for Canadians with serious, life-threatening conditions. These "open-label individual patient" studies are being carried out for those who are not eligible for or have exhausted alternative treatment options.
Special access products more readily available
Our Special Access Programme allows physicians and other health professionals to request access, for a specific patient, to a drug that has not yet been approved for use in Canada, when conventional approved therapies have failed, are unsuitable, or offer limited options. To support more straightforward retrieval of drugs frequently accessed through this programme, we approved several products that can now be prescribed directly by health professionals. For example, Ranexa (ranolazine) to treat heart-related chest pains, EVRYSDI (risdiplam) to treat spinal muscular atrophy, and Effient (prasugrel) to prevent the formation of blood clots, which used to be requested by health professionals more than 50 times per year through the Special Access Programme, can now be prescribed directly.
Working with global partners
In collaboration with the Access Consortium, we worked with partners in Australia, Canada, Singapore, Switzerland and the United Kingdom to approve new drugs.
In collaboration with the United States, through Project Orbis, we approved Retevmo (selpercatinib) to treat three different types of cancer (including tumours in pediatric patients). Also through Project Orbis, in collaboration with the United States, Australia, Singapore, Switzerland and Brazil, we approved Tagrisso (osimertinib) for patients with non-small cell lung cancer.
These are only some examples of how we work closely with our international regulatory partners to bring much needed health products to Canadians. We will continue to play a leadership role at the global level to maintain Canada's world-class regulatory system.
Between January and June, we authorized 43 new drugs (including three new biosimilar drugs) and 82 new generic drugs.
Improving access to over-the-counter (non-prescription) drugs and natural health products
Between January and June, we authorized 163 new over-the-counter drugs, including antiseptics, nonsteroidal anti-inflammatory drugs, analgesics/antipyretics, anti-allergy drugs, and sunscreens. We also authorized 4,149 natural health products, including alcohol based hand sanitizers, probiotics, herbal remedies, vitamins and minerals. More information can be found in the Licensed natural health products database and the Drug product database online query.
Work moves forward on regulatory modernization, including through extensive consultation with stakeholders. As part of Phase I of the Self-Care Framework, we are proposing regulatory and policy changes to improve the labelling of natural health products. Work is also underway on a proposal to introduce flexibilities for biocides and to place them under a single regulatory framework.
The Commissioner of the Environment and Sustainable Development report on the audit of the Natural Health Products Program was tabled in Parliament on April 22, 2021. Health Canada accepted each of the Commissioner's recommendations and is already taking steps to accelerate its efforts to strengthen the Program, including increasing oversight of quality, advertising and labelling, and piloting proactive inspections.
Improving access to drugs for veterinary use
We are moving ahead on work to protect human and animal health and the safety of Canada's food supply. Between January and June, we authorized seven veterinary drugs and accepted 199 veterinary health product notifications.
|January||Nexgard Combo (praziquantel, afoxolaner, eprinomectin)||
|February||Solofer (iron dextran complex)||Used to treat and prevent iron deficiency anemia in newborn piglets.|
|February||Librela (bedinvetmab)||Alleviates pain associated with osteoarthritis in dogs.|
New generic drugs
|February||Tilmovet AC (tilmicosin phosphate)||May help to reduce the severity of swine respiratory disease.|
|February||Bacitracin MD Soluble (bacitracin methylene disalicylate)||May help to prevent necrotic enteritis in broiler chicken.|
|March||Respotil (tilmicosin phosphate)||May help to reduce the severity of swine respiratory disease.|
|June||Increxxa (tulathromycin)||Used to treat bovine/swine respiratory disease, infectious conjunctivitis in cattle, and foot rot in sheep and cattle.|
Improving access to medical devices
We continue to implement measures per our Action plan on medical devices to improve the safety of medical devices marketed in Canada. We recently published a Medical devices action plan: Progress report that highlights activities and achievements related to the Action Plan's objectives, including:
- launching a public consultation regarding clinical trial modernization;
- consulting Health Canada's Scientific Advisory Committees with respect to health products for women, digital health technologies, and medical devices used in the cardiovascular system; and
- hosting four webinars that offered guidance on the strengthened final regulations regarding the post-market surveillance of medical devices.
We licensed 30 new Class IV medical devices and 139 new Class III medical devices between January and June 2021. We also authorized 167 COVID-19 devices under the Interim Order for medical devices during that period.
|January||Achieve Advance Mapping Catheter||Used in electrophysiological mapping of the cardiac structures of the heart.|
|January||HeartStart Intrepid Monitor/Defibrillator||Used in emergency resuscitation to defibrillate the heart.|
|January||SoundBite Crossing System - Peripheral (14P)||Used for placement of conventional guidewires or treatment devices beyond peripheral artery chronic total occlusions via atherectomy.|
|February||Mynx Control Vascular Closure Device||Used to seal femoral arterial access sites while reducing times to hemostasis and ambulation in patients who have undergone diagnostic or interventional endovascular procedures.|
|February||OmniWire Pressure Guide Wire||Used to measure pressure in blood vessels during diagnostic angiography and/or any interventional procedures, and to facilitate the placement of catheters as well as other interventional devices in coronary and peripheral vessels.|
|February||Pulsar-18 T3 Peripheral Self-Expanding Nitinol Stent System||Used to improve luminal diameter in patients with symptomatic de novo, restenotic or occlusive lesions in the femoral and proximal popliteal arteries.|
|February||Stealth 360 Peripheral Orbital Atherectomy System||Used as therapy in patients with occlusive atherosclerotic disease in peripheral arteries who are acceptable candidates for percutaneous transluminal atherectomy.|
|March||Alto Abdominal Stent Graft System||Used for treatment of patients with infrarenal abdominal aortic aneurysms which have the vascular morphology suitable for endovascular repair with the device.|
|March||Orsiro Sirolimus Eluting Coronary Stent System||Used for improving coronary luminal diameter in patients.|
|March||ZOLL AED 3 Aviation||Used when a suspected cardiac arrest victim has an apparent lack of circulation, automatically activating defibrillation of the heart through application of electrical shocks to the chest surface.|
|April||COMET II Pressure Guidewire||Used to direct a catheter through a blood vessel and to measure physiological parameters in the coronary blood vessels.|
|May||EmboCube Embolization Gelatin||Used in embolization of blood vessels to occlude blood flow, in order to control bleeding or hemorrhaging.|
|May||EMBOTRAP III Revascularization Device||Intended to restore blood flow in the neurovasculature within 8 hours of symptom onset by removing thrombus in patients experiencing ischemic stroke.|
|May||Tornado Embolization Coils And Microcoils||Intended for arterial and venous embolization in the peripheral vasculature.|
Gastroenterology and urology
|March||Sapphire II PRO Balloon Dilatation Catheter||Used for balloon dilatation of artery or bypass graft stenosis for the purpose of improving myocardial perfusion or the treatment of acute myocardial infarction.|
|April||TriClip G4 System||Used for reconstruction of the insufficient tricuspid valve through tissue approximation.|
General and plastic surgery
|February||neXus Ultrasonic Surgical Aspirator System||Intended for the fragmentation, emulsification and aspiration of both soft and hard (i.e., bone) tissue.|
|January||PK CMV-PA System||Used as a passive particle agglutination assay intended for the qualitative detection of IgG and IgM antibodies to cytomegalovirus (CMV) in human EDTA plasma and serum from blood donors.|
|March||Atellica IM HBc Total 2||Used for in vitro diagnostic in the qualitative determination of total antibodies to the core antigen of the hepatitis B virus in human serum or plasma.|
|January||WaveWriter Alpha Spinal Cord Stimulator System||Indicated as an aid in the management of chronic intractable pain.|
|March||eCLIPs System||Intended to treat intracranial saccular aneurysms that was unruptured, stable, or previously ruptured in over 30 days.|
|March||WaveWriter Alpha Spinal Cord Stimulator System - Alpha 16||Indicated as an aid in the management of chronic intractable pain.|
|March||WaveWriter Alpha Spinal Cord Stimulator System - Alpha Prime||Indicated as an aid in the management of chronic intractable pain.|
|March||WaveWriter Alpha Spinal Cord Stimulator System - Alpha Prime 16||Indicated as an aid in the management of chronic intractable pain.|
|May||Nester Embolization Coils and Microcoils||Intended for arterial and venous embolization in the peripheral vasculature.|
Publicly released clinical information
We are now in our third year of releasing clinical information that was used to decide whether a drug or medical device can be sold in Canada. The clinical information published through Health Canada's Clinical Information Portal has been viewed and downloaded tens of thousands of times, and the scope of information being published continues to grow.
Clinical information on drugs and medical devices published between January and June is listed below.
|January||Bamlanivimab (LY3819253)||Antibody therapy used to treat cases of mild to moderate COVID-19 infection at high risk of disease progression in patients 12 years of age and older.|
|January||Inrebic (fedratinib)||Used to treat adult patients with intermediate-2 or high-risk primary or secondary myelofibrosis (blood cancer/leukemia).|
|February||Lescol (fluvastatin)||Statin used to lower blood pressure.|
|February||Pravachol (pravastatin)||Statin used to lower blood pressure.|
|February||Luxturna (voretigene neparvovec-rzyl)||Gene-therapy used to treat certain adult and pediatric patients with inherited retinal dystrophy.|
|February||Suboxone (buprenorphine)||Substitution treatment used for opioid drug dependence in adults, indicated for use within a framework of medical, social and psychological support.|
|February||Sovaldi (sofosbuvir)||Used in combination with antiviral treatments to treat adults with chronic hepatitis C.|
|February||Givlarii (givosiran)||Used to treat adult patients with acute hepatic porphyria (a hereditary liver disease).|
|March||Tissueblue (brilliant blue G ophthalmic solution)||Ophthalmic surgery aid used to stain the internal limiting membrane of the eye.|
|March||Daurismo (glasdegib)||Used to treat acute myeloid leukemia that has not been treated before in adults 75 years of age and older, or in those who cannot receive intensive chemotherapy.|
|March||Moderna COVID-19 Vaccine (nucleoside modified)||Active immunization to prevent COVID-19 caused by SARS-CoV-2 in individuals 18 years of age and older.|
|March||Opdivo (nivolumab)||Used alone or in combination with Yervoy (ipilimumab) to treat a variety of cancers.|
|March||Pfizer-BioNTech COVID-19 Vaccine (tozinameran)||Active immunization to prevent COVID-19 caused by SARS-CoV-2 in individuals 12 years of age and older.|
|March||Zeposia (ozanimod)||Used to treat adults with relapsing remitting forms of multiple sclerosis.|
|March||Lipitor (atorvastatin)||Statin used to lower blood pressure.|
|April||Corzyna (ranolazine)||Add-on therapy used for symptomatic treatment of stable angina resultant from heart disease in adults.|
|April||Adacel-Polio (Tdap polio)||Active booster immunization used for prevention of tetanus, diphtheria, pertussis and poliomyelitis in individuals 4 years of age and older.|
|April||Supemtek (quadrivalent influenza vaccine)||Recombinant influenza A and B vaccine for adults.|
|April||Dayvigo (lemborexant)||Used to treat adult patients with insomnia.|
|April||Tavalisse (fostamatinib)||Used to treat chronic immune thrombocytopenia (low blood platelets) in adult patients unresponsive to other treatments.|
|April||Belkyra (deoxycholic acid injection)||Cosmetic treatment for submental (under-chin, neck) fat in adults.|
|April||Abilify Maintena (aripiprazole)||Used to treat adults with schizophrenia.|
|May||Xenleta (lefamulin)||Used to treat adults with community-acquired pneumonia.|
|May||Lancora (Ivabradine)||Used to treat adult patients at risk of complications from chronic heart failure.|
|May||Apo-Tenofovir (tenofovir disoproxil fumarate)||Used in combination with other antiretroviral agents to treat HIV-1 infection in patient 12 years of age and older and chronic Hepatitis B infection in adults.|
|May||Zocor (simvastatin)||Statin to lower blood pressure.|
|May||Vascepa (icosapent ethyl)||Used to reduce cardiovascular events, such as heart attacks or strokes in high-risk adult patients with high blood cholesterol.|
|May||Lescol (fluvastatin)||Statin used to lower blood pressure.|
|May||Bavencio (avelumab)||Used to treat metastatic Merkel cell carcinoma in patients 12 years of age and older.|
|May||Repatha (evolocumab)||Used to treat hyperlipidemia in adult patients with cardiovascular disease who are at risk of heart attack or stroke.|
|June||Amoxicillin Sodium and Potassium Clavulanate for injection (amoxicillin, clavulanic acid)||Used for treatment of bacterial infections.|
|June||Pravachol (pravastatin sodium)||Statin to lower blood pressure.|
|June||Opdivo (nivolumab)||Used for treatment of inoperable/metastatic melanoma (skin cancer) in previously untreated adults.|
|June||Symbicort 100, 200 Forte Turbo Inhaler (budesonide, formoterol fumarate dehydrate)||Used for the control and prevention of symptoms associated with asthma or COPD.|
|June||Brukinsa (zanubrutinib)||Used for treatment of Waldenstrom's macroglobulinemia (a type of Non-Hodgkin lymphoma).|
|June||Zolgensma (onasemnogene abeparvovec)||A gene-therapy indicated for treatment of spinal muscular atrophy in pediatric patients less than 2 years of age.|
|February||Baylis V4C-560 Ventilator||Respiratory ventilator for use on adults with severe symptomatic respiratory illness.|
|March||ID NOW COVID-19||PCR-based qualitative test device indicated for use in support of clinical diagnosis re: COVID-19 infection.|
|March||The Spartan COVID-19 V2 System||PCR-based qualitative test device indicated for use in support of clinical diagnosis re: COVID-19 infection.|
|March||TECNIS Multifocal 2.75D ADD 1-piece Intraocular Lens / TECNIS Multifocal 3.25D ADD 1-piece Intraocular Lens||Implantable medical device used for correction/restoration of vision after cataract removal in adults.|
|April||AT LISA tri||Implantable medical device used for the treatment of presbyopia in adults.|
|April||Sofia SARS Antigen FIA||Test device indicated for use in support of COVID-19 diagnosis.|
|June||BKIT Virus Finder COVID-19||PCR-based qualitative test device indicated for use in support of COVID-19 diagnosis.|
|June||CUE COVID-19 Test||PCR-based qualitative test device indicated for use in support of COVID-19 diagnosis.|
Adverse reactions and incidents
Since mandatory hospital reporting was implemented in Canada in December 2019, Health Canada's Canada vigilance program (CVP) has received a high number of serious Adverse reaction (AR) and Medical device incident (MDI) reports from more than 800 hospitals. These reports provide valuable information used in the identification and assessment of new safety signals.
The following table presents the number of domestic Adverse events following immunization (AEFI) reports, Adverse reaction (AR) reports, and Medical device incident (MDI) reports regarding COVID-related products received by the Canada vigilance program between January and June.
|COVID-19 related products||Total number of AEFIs, ARs and MDIs received by the Canada Vigilance Program
January to June 2021
|Number of serious reports|
|COVID-19 Vaccines (see below Table footnote 1 re: total)||1912Table footnote 1||1624|
|Pfizer-Biontech COVID-19 Vaccine (Tozinameran)||1243||1094|
|Moderna COVID-19 Vaccine (MRNA-1273 SARS-COV-2)||216||145|
|AstraZeneca COVID-19 Vaccine (ChAdOx1-S) / COVISHIELD||347||294|
|COVID Vaccine reports where brand name not specified||106||91|
|Medical Device Incidents Reported on COVID-related Medical Devices (see belowTable footnote 2 re: total)||939Table footnote 2||90Table footnote 2|
We are proud of the progress we have made as we continue to serve the needs of Canadians, and are committed to moving forward, together with our partners, stakeholders, and Canadians, toward a post-pandemic future.
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