Mid-year update: Drugs and medical devices approved in 2020

Learn about our work to support Canada's response to COVID-19, the new drugs and medical devices that Health Canada approved for sale in Canada and clinical information 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 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're pleased to provide you with an update on the key drugs and medical devices approved by Health Canada between January and June 2020.

Over the past 6 months, our focus has been mainly on supporting the fight against COVID-19. This pandemic has created an unprecedented demand on Canada's health care system. Health Canada has played a key role in Canada's response to COVID-19 by working with partners and stakeholders to ensure essential health products and medical supplies are available for Canadians.

Early on, we implemented innovative and agile measures to help prioritize and expedite the regulatory review of COVID-19 health products. We did this without compromising Canada's high standards for safety, efficacy and quality. We continue to work with domestic and international players to help accelerate the development and availability of drugs and vaccines that will prevent and treat COVID-19.

In addition to supporting Canada's response to COVID-19, we also continued to authorize many other drugs and medical devices. These health products are vital to the health and well-being of Canadians.

Lastly, we recently published our 5^th annual Drug and Medical Devices Highlights Report. Please see Drug and Medical Device Highlights 2019: Helping you Maintain and Improve your Health to learn more about our accomplishments in 2019.

These extraordinary times have changed the way we work, collaborate and innovate. We will build on this experience to inform future approaches to regulation that promote innovation, regulatory agility and safety. Moving forward, we will continue to work with our partners to provide products and information that Canadians need to stay safe and healthy.

Pamela Aung Thin
Associate Assistant Deputy Minister
Health Products and Food branch

Pierre Sabourin
Assistant Deputy Minister
Health Products and Food Branch

Our COVID-19 regulatory response

As the national regulator for health products, Health Canada plays an important role in Canada's response to the COVID-19 pandemic.

Our regulatory measures and guidance have allowed companies to put vital products such as personal protective equipment, testing devices and hand sanitizers into the hands of Canada's health care workers and the Canadian public quickly. They help expedite clinical trials that support the rapid development of potential COVID-19 treatments and vaccines. The exceptional importation of drugs and medical devices that Canadians rely on for their health has also helped to prevent and ease shortages.

These and other efforts by Health Canada have made a strong impact on Canada's public health response to COVID-19.

The health products sector and Canada's business community mobilized quickly. Health Canada collaborated with federal partners and international counterparts. Due to these collective efforts, we approved thousands of products between March and June. These products support areas of greatest need and include more than:

• 3,200 hand sanitizers and
• 149 hard-surface disinfectants
• 262 medical devices for patient safety and care, such as personal protective equipment, ventilators and decontamination devices
• 26 testing devices for diagnosing COVID-19 and detecting the antibodies produced in response to a COVID infection
• 40 clinical trials, including the first clinical trial in Canada for a COVID-19 vaccine

We're working with industry, health care professionals and regulatory partners to monitor the real-world effectiveness of products once they're approved. We're also taking proactive measures to protect Canadians from those products that make false or misleading COVID-19 claims.

Finally, we continue to leverage international collaborations to inform our regulatory strategies while contributing to global solutions for COVID-19.

Improving access to drugs for human use

In addition to our response to COVID-19, Health Canada continues to authorize products that are vital to the health and well-being of Canadians. Over the past 6 months, we authorized a number of new drugs to improve available treatment options.

Among these authorizations, we approved a pediatric formulation for caffeine citrate in March. This drug meets a longstanding need for treating serious breathing problems that can occur in premature infants in neonatal intensive care units.

In collaboration with the Australia-Canada-Singapore-Switzerland Consortium, Health Canada worked with partners to approve new drugs and get them to the market quickly and efficiently. In February we approved Xofluza to treat influenza, in partnership with Australia and Switzerland.

This is only one example 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.

We authorized 35 new drugs (including 7 new biosimilar drugs) and 63 new generic drugs since January 2020.

Improving access to drugs for veterinary use

Health Canada continues to work to protect human and animal health and the safety of Canada's food supply. We authorized 10 veterinary drugs since January 2020.

Improving access to medical devices

In January 2020, we created the Medical Devices Directorate to regulate medical devices for human use. This new Directorate is responsible for the pre-market review and post-market surveillance of medical devices. The Directorate verifies the safety, effectiveness and quality of medical devices and monitors the evolving safety of devices already on the market. It is important that Canadians have access to effective devices while not being exposed to undue risks.

We have also continued to improve the safety of health products marketed in Canada. Our Action Plan on Medical Devices, launched in December 2018, outlines measures that will:

• improve how medical devices get on the market
• strengthen monitoring and follow-up and
• provide Canadians with more information about the medical devices they rely on

We licensed 21 new Class IV medical devices and 128 new Class III medical devices since January 2020.

Publicly released clinical information

We now release the clinical information that was provided to us by companies, after we have made our final decision as to whether a drug or medical device can be sold in Canada. Clinical information on drugs and medical devices published since January is listed below. It is also available through our portal. Information about drugs and medical devices already on the market can be added to the portal upon request.

Adverse reactions and incidents

As of December 16, 2019, hospitals must now report all serious adverse drug reactions (ADRs) and medical device incidents (MDIs). Health Canada is the first regulator worldwide to take this major step. This new requirement increases the quality and quantity of data we receive, thereby ensuring we have the necessary information to detect and take action to reduce health risks to Canadians.

Over 800 hospitals across Canada are now required to report ADRs and MDIs. Since implementing this new mandate, the number of reports have increased every month. Since January, we've received 2,731 serious ADR reports and 2,673 MDI reports from hospitals. Compared to the same period last year, this reporting by hospitals represents a:

• 4.5-fold increase in the number of ADR reports and
• 12-fold increase in the number of MDIs

We're grateful to the many hard-working health care practitioners who are taking enhanced steps to protect Canadians from the risks of harmful products.

Conclusion

We're proud of the progress we've made to serve the needs of Canadians during these challenging times. We're also proud to have collaborated with our Canadian and international partners, in supporting Canada's response to combatting COVID-19.