Drug and medical device highlights 2020: Helping you maintain and improve your health
Organization: Health Canada
Health Canada helps Canadians maintain and improve their health by providing timely access to safe and effective drugs and medical devices. Learn about the new drugs and medical devices that Health Canada approved for sale in Canada, the information we published about these products, and our other accomplishments in 2020.
On this page
- Welcome to our 2020 highlights report
- Message from the Chief Medical Officer
- Message from the Chief Regulatory Officer
Welcome to our 2020 highlights report
We have witnessed unprecedented challenges this year, following the outbreak of COVID-19. In addition to our core responsibilities, our response to the pandemic defined much of our work in 2020.
Health Canada worked closely with stakeholders and government partners to understand and address the challenges faced by the health care system and communities across the country. We collaborated with regulators from other countries as well as international organizations to align our approach with the global response to COVID-19. We mobilized to respond to the areas of greatest priority for drugs and medical devices, as well as for disinfectants and hand sanitizers.
Of course, our core responsibilities did not stop with the pandemic. We continued to approve medical devices along with drugs for human and veterinary use, to ensure that Canadians had access to these important products. Further, we continued our work on priority projects, such as the Medical Devices Action Plan, our new Pediatric Drug Action Plan and addressing antimicrobial resistance.
This report describes the new drugs and medical devices that Health Canada approved for sale in Canada, the information we published about these products and our other accomplishments. It also provides insight into our response to the pandemic, including our role in expediting the review of needed health products and medical devices that test for, treat and prevent COVID-19.
As with previous years, the Highlights report is divided into three chapters: drugs for human use, medical devices and drugs for veterinary use. We have continued our "Focus on…" features, which provide a closer look into our priorities in 2020. In each chapter, we begin with a discussion of our response to the COVID-19 pandemic and then address other priorities.
For the most up-to-date information on our activities, see the "Healthy Clicks" sections. We also invite you to follow @GovCanHealth and @CDNMinHealth on Twitter to learn about newly approved drugs and medical devices.
At the onset of the pandemic, there was an urgent need for safe and effective health products and medical devices that would help limit the spread of the novel coronavirus.
Health Canada quickly reached out to our stakeholders and worked with our international partners. We put in place a regulatory approach that focused on flexibility, while maintaining safety and efficacy of regulated products for COVID-19.
Throughout the pandemic, we engaged our stakeholders to better support access to health products for COVID-19. Our discussions focused on potential health product solutions, and collaborating with other government departments to address challenges in getting COVID-19 products to market.
We worked quickly to support businesses that were eager to mobilize needed products. We provided guidance and advice on regulatory requirements, and enhanced the information on our websites.
We also helped equip health care professionals and Canadians with information about the products we approved. This includes a new portal with information about the vaccines and treatments for COVID-19.
The pandemic prompted an unprecedented level of collaboration among the regulatory community around the world. We worked with other regulators to align our regulatory response, coordinating our strategies and guidance.
We also worked with key regulatory partners to share information and expertise on the review and monitoring of COVID-19 health products.
COVID-19 health products
In responding to the pandemic, we focussed on allowing flexibility without compromising our standards for safety, efficacy and quality. We put in place measures to prioritize and help expedite the review of:
- disinfectants and hand sanitizers,
- medical devices, such as ventilators, testing devices and personal protective equipment (PPE), and
- vaccines and treatments.
Central to this response were five Interim Orders. An interim order is one of the fastest regulatory tools available to help address large-scale public health emergencies. The Interim Orders helped to:
- facilitate the conduct of clinical trials and broaden access for trial participants,
- establish temporary approval pathways to expedite the review of medical devices and drugs,
- allow exceptional importation of drugs, medical devices or foods for a special dietary purpose, and
- provide additional tools to help prevent and alleviate shortages of drugs and medical devices that may have been caused or worsened by the COVID-19 pandemic.
Additional measures and guidance helped to support industry in meeting the incredible demand for health products.
In 2020 we approved the following for use in COVID-19:
- over 4,400 hand sanitizer products,
- approximately 200 disinfectants,
- 545 medical devices,
- 81 clinical trials for drugs and 18 for medical devices,
- 2 drug treatments, and
- 2 vaccines.
We will continue to monitor the safety and effectiveness of these and any additional vaccines, and all other COVID-19-related products.
These remain extraordinary times. Moving forward, we will leverage the insights learned from the pandemic response to inform future approaches to regulation that promote agility, innovation and safety, while continuing to work with our partners to provide the health products and information that Canadians need.
It takes a team to regulate the products that are profiled in the 2020 Drug and Medical Device Highlights report. For example, biologists, chemists, biostatisticians, medical doctors, veterinarians, engineers, economists and regulatory officers play a key role in the various steps in our regulatory processes. They are supported by administrative and human resource officers, policy and business analysts, scientific writers, lawyers and students within our workforce.
"Our team is highly skilled, professional and dedicated to their work. In 2020 we tackled unprecedented issues and enormous workloads, all while maintaining our connections in a virtual environment. I would like to sincerely thank our employees for their extraordinary work this year, under such unique and challenging circumstances."
Assistant Deputy Minister
Message from the Chief Medical Officer
This past year brought much attention to the role the Health Canada plays as an integral part of the healthcare system. Whether it was for health products such as diagnostic tests for COVID-19, or reviews of new vaccines, the rapid pace of science innovation highlighted the key gatekeeper function of the department. Many people became aware of a regulatory system that had otherwise functioned quietly in the background, assuring that the health products they needed were diligently reviewed and met the high standards for safety, efficacy and quality that underpin all authorization decisions.
Being open and transparent brought into focus the importance of having an independent regulator that based decisions solely on science and evidence, while being flexible and agile to respond to the public health crisis that faced us all. There was interest in the details of the review processes, the competencies and experience of reviewers, the volumes of data that are assessed prior to decisions being made, and the critical role of balancing benefits, risks and uncertainties. Areas such as international cooperation and collaboration were brought to the fore as essential in coming up against a global pandemic.
All of this was in service of ensuring that people could have faith and confidence in the regulatory role and they could be assured that those who were making those decisions genuinely had "been training their whole lives for this".
As challenging as the previous year was, one benefit has been this greater understanding of the importance of being able to equip oneself with information from trusted sources to empower people to be able to make the best decisions for their own health and wellbeing. This is as true in "non-pandemic" times as it is now.
The collective challenge to all of us is to continue this sharing of information, innovative practices, and engagement as we go forward.
Message from the Chief Regulatory Officer
The COVID-19 pandemic has led to the implementation of a series of extraordinary regulatory measures. These have provided Health Canada with the flexibilities we needed to respond effectively and efficiently to the crisis.
In March, Health Canada was part of the Government's COVID-19 Emergency Response Act. This legislation was enacted to stabilize the Canadian economy and protect Canadians' health and safety. Among other components, the Act gave the Government the authority to make regulations to help prevent or alleviate shortages of drugs and medical devices. This helped facilitate access for Canadians to supplies of drugs and medical devices, including personal protective equipment, that were needed to address the public health emergency.
Health Canada also put in place five Interim Orders to respond to the urgent need for access to health products as a result of the COVID-19 pandemic. An interim order is one of the fastest mechanisms available to the federal government to help address larger-scale public health emergencies.
- The Interim Order Respecting the Importation and Sale of Medical Devices for Use in Relation to COVID-19 Archived ensured that medical devices that are integral to the diagnosis, treatment, mitigation or prevention of COVID-19 could be quickly authorized for sale or importation while maintaining high scientific standards. It allowed Health Canada to impose terms and conditions on the authorization of a medical device under the Interim Order, so that we could act quickly to collect information or take action to mitigate risks associated with a product.
- The Interim Order Respecting Drugs, Medical Devices and Foods for a Special Dietary Purpose in Relation to COVID-19 Archived allowed the Minister to permit the exceptional importation and sale of drugs and medical devices experiencing a shortage in Canada that were approved in other countries with comparable approval systems. Additionally, the Interim Order introduced a mandatory mechanism for the Minister to be notified of shortages of critical medical devices. Finally, the Interim Order allowed for the expedited authorization of hard surface disinfectants and hand sanitizers.
- The Interim Order Respecting Clinical Trials for Medical Devices and Drugs Relating to COVID-19 Archived allowed the authorization process for COVID-19-related clinical trials to be more efficient and flexible, without compromising the safety of participants or the reliability of trials' findings. This flexibility also facilitated broader patient participation across the country by allowing a wider range of health professionals or investigators to be involved in carrying out clinical trials. For example, the Interim Order allowed for remote patient consent; this was not only critical during the pandemic but in the future it could become a policy to help patients participate in clinical trials from more remote communities.
- The Interim Order Respecting the Importation, Sale and Advertising of Drugs for Use in Relation to COVID-19 introduced expedited authorization pathways for the importation, sale and advertising of drugs (human and veterinary) used in relation to COVID-19. The Interim Order established expedited processes including rolling submissions, where companies provide data to Health Canada as it becomes available. Companies must continue to demonstrate that their drugs (including vaccines) are safe, effective and of high quality. Health Canada can impose terms and conditions on the authorization of a drug, allowing us to act quickly to gather important safety information or mitigate risk.
- The Interim Order on Preventing and Alleviating Drug Shortages in Relation to COVID-19 provided Health Canada with more tools to urgently address drug shortages related to COVID-19. This authority will help safeguard Canada's drug supply and ensure that Canadians have access to the medicines they need.
In 2020 we also finalized changes to the Food and Drug Regulations to modernize the Special Access Program for human drugs, and the Emergency Drug Release program for drugs for veterinary use. These changes improved the processes used by health care providers and reduced the administrative burden for requests to access drugs that are not yet authorized for sale in Canada, for COVID-19 and other medical emergencies.
In order to appropriately implement a life-cycle approach for medical devices, Health Canada required additional authorities to monitor devices once they are on the market. Vanessa's Law amended the Food and Drugs Act to strengthen our ability to collect post-market safety information and take appropriate action when needed. In 2020 we published regulations relating to the post-market surveillance of medical devices, which implemented certain provisions of Vanessa's Law and additional measures to improve post-market surveillance. Together these efforts have helped to reduce the risk of medical devices and improve their safety, quality and effectiveness.
Our regulatory work in 2020 has focused primarily on Health Canada's urgent response to the COVID-19 pandemic. We will continue our work to maintain the flexibilities and regulatory oversight provided by the Interim Orders until at least the fall of 2021. By then, Health Canada intends to bring forward regulatory amendments that would allow for the transition of products already authorized so that they can continue to be sold.
Moving forward, we will turn our attention back to the activities we had previously planned, related to regulatory innovation. We will continue to build on the lessons learned from our regulatory response to COVID-19 to shape our new, agile regulatory frameworks.
Advancing our policy and regulatory agenda
At the core of our mandate is a set of legislative and regulatory frameworks that allow Health Canada to maintain high safety, quality, and efficacy standards for drugs and medical devices. We are dedicated to transforming our regulations to become more agile, transparent, and aligned with our counterparts in other countries.
Our strong relationships with partners and stakeholders help us advance our policy and regulatory agenda. We provide leadership and strategic advice in addressing emerging issues, collaborate with international counterparts, and communicate priorities and plans to Canadians, Parliamentarians and stakeholders.
The foresight activities we conduct will also help inform agile approaches to regulation that support innovation and safety. Stakeholder forums and scientific advisory committees help strengthen our evidence-based policy development and decision making, and help maintain our strong commitment to transparency.
To learn more about our future regulatory initiatives, go to Health Canada's Forward Regulatory Plan for 2021-23.
Ensuring a properly funded and transparent regulatory system
Following extensive consultation with stakeholders, Health Canada successfully implemented our new cost recovery regime on April 1, 2020 using the new authorities we received in 2017.
The new regime allowed us to better align with the fees charged by other regulators such as the European Medicines Agency and the United States Food and Drug Administration for the delivery of similar regulatory services, for activities like the scientific review of new drugs and medical devices. The new regime also introduced a small business strategy to reduce barriers to innovation by providing fee relief to qualifying businesses, and waiving fees for publically-funded health care institutions.
The new authorities used to implement the new regime allow us to set and adjust fees in a timely and flexible manner, to respond to regulatory challenges. For example, we were able to swiftly waive fees for the scientific review of COVID-19 drugs and medical devices filed under the interim orders, to better respond to the public health emergency.
In 2020, we also continued to make great strides in openness and transparency. Although we just began to publish clinical information about safety and efficacy of drugs and medical devices in 2019, we published over 124 packages in just two years of operation, containing over 2.5 million pages of clinical information. The value of this initiative was also demonstrated in the context of the pandemic, when we published clinical data for nine COVID-related drugs and medical devices. Three of these were published as a result of a close working relationship with the European Medicines Agency.
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