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
• Conclusion

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.

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

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.

Vaccines

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.

International collaboration

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.

Expedited review

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.

Drug authorizations

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.

Regulatory modernization

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.

Strengthened programming

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.

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.

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.

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.

Conclusion

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.