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Learn about our work to support Canada’s response to COVID-19, new drugs, medical devices, over-the-counter products and natural health products that Health Canada has approved for sale in Canada, as well as published clinical information.

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Message from the Assistant Deputy Ministers.Our regulatory response to COVID-19.Improving access to medicines for human use.Improving access to over-the-counter drugs (non-prescription drugs) and natural health products.We are pleased to provide an update on drugs, medical devices, over-the-counter drugs (non-prescription drugs) and natural health products approved by Health Canada between January and June 2021.The regulatory response to COVID-19 continued to play a key role in our work. This includes the approval of three additional COVID-19 vaccines, as well as ongoing and rigorous post-marketing surveillance of COVID-19-related products.

Although these are extraordinary times, we are committed to working with our partners and stakeholders to provide the products and information Canadians need to stay healthy and safe as we move together towards a post-pandemic future.As the national health product regulator, we continue to play a key role in Canada’s ongoing response to the COVID-19 pandemic. Since the onset of the pandemic, we have leveraged an agile regulatory approach, which includes the introduction of emergency regulatory pathways and measures to support accelerated access to health products needed to combat COVID-19.Health Products: ApprovalsFor example, on April 8, 2021, we authorized a tailored treatment platform trial for outpatients with COVID-19 (by the National Institute of Allergy and Infectious Diseases ) to assess the safety and effectiveness of different drugs for treating COVID-19 in outpatients. This could help prevent more serious symptoms and complications and the spread of COVID-19 in the community.

On May 5, 2021, we authorized the MOSAIC ( COVID-19 Vaccine Second Dose Mixture for Safety and Immunogenicity ) study. This Canadian study examines the safety and immune response of mixing and matching approved COVID-19 vaccines using various time intervals in adults.Additionally, Medicago’s coronavirus-like recombinant particle COVID-19 plant vaccine is now in Phase III clinical trials. Medicago’s COVID-19 vaccine is the first Canadian-made vaccine in a Phase III trial. It is also unique in that it incorporates plant-based protein.

Vaccines

Since we approved the Pfizer and Moderna vaccines against COVID-19 in December 2020, we have licensed three more vaccines, namely Janssen, AstraZeneca and Serum Institute of India’s version of the AstraZeneca vaccine, COVISHIELD.

On May 5, 2021, we approved Pfizer-BioNTech’s COVID-19 vaccine for use in children 12-15 years old. This is the first COVID-19 vaccine authorized in Canada for this age group, marking an important milestone in Canada’s fight against the COVID-19 pandemic.

Regulatory review and oversight of these products continues, and updated regulatory and product information is added to the COVID-19 vaccines and treatments portal on an ongoing basis.

Self-diagnostic and point-of-service instruments

As we continue to adapt to the changing challenges of the pandemic, review of self-diagnostic and point-of-care instruments (which can be used by trained operators) is a priority to support better access to COVID-19. The first COVID-19 self-diagnostic instrument was authorized for sale in April 2021. Further information on self-diagnostic and point-of-care instruments is available on the website.

Hand antiseptics and disinfectants

We also continued our efforts in this area in response to COVID-19, authorizing 182 hand sanitizers and 96 sanitizers between January and June. Further 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; hand sanitizers containing technical grade ethanol; 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.

Data from these safety monitoring and surveillance activities helped Health Canada’s scientific and medical staff collect and analyze product safety information (including adverse event reports), perform safety assessments, apply risk management measures, and communicate the risks associated with these products to the public and health care professionals.

International cooperation

We continue to work with our international partners and participate in discussions about new treatments and vaccines for COVID-19, including the actual safety and effectiveness of these products. Together with the Public Health Agency of Canada, we collaborate globally on research, take proactive steps to identify adverse events, and quickly implement risk management measures, such as up-to-date labeling and risk communication. Further information on international engagement is available on the website.

Published data and information

We continue to post regulatory and product information on Health Canada’s website and on the COVID-19 Vaccines and Treatments portal to support the strong demand for credible scientific data.

Updated authorization requirements

On March 18, 2021, we introduced transitional 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 transitional measures ensure that Canadians have continued and timely access to safe, effective and quality COVID-19 medicines.

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