Health product highlights 2021: Helping you maintain and improve your health

Our work continues even after we review and authorize health products for use in Canada. We continue to monitor COVID-19 products and provide updated safety information as additional data becomes available. Combatting misinformation in marketing has been more important than ever. We track false and misleading claims about COVID-19 products and issue science-based advice. This, along with our efforts to enhance the transparency of health product information provided to Canadians, helps to ensure that they are able to make informed decisions.

We want to acknowledge the extraordinary efforts of our employees – a team highly specialized across a variety of disciplines – in bringing their expertise to bear to help Canadians through this health crisis. Their work has built trust in our regulatory system, provided clear, authoritative information to the public, and above all, ensured the safety, efficacy and quality of thousands of new products – enabling access to both COVID-related products while continuing to review and authorize the many other health products Canadians rely on.

We would be remiss if we did not also mention the contributions of Pierre Sabourin, who retired from the public service in December 2021. He led the Health Products and Food Branch as Assistant Deputy Minister for six years, including through the demanding first 20 months of the COVID-19 pandemic. His dedication and commitment to public service have been outstanding.

An enormous amount of stakeholder collaboration has also taken place over the past two years. We are one piece of the broader COVID-19 response, and we have worked with our federal government partners, provincial and territorial governments, product sponsors, including manufacturers and researchers, and health care practitioners on a scale that we have never seen before. This included scanning for emerging COVID-19 products, and proactively engaging with manufacturers to encourage them to submit their products for approval in Canada. We also continued to prioritize collaboration with our international regulatory partners, in order to support timely access to new products for Canadians. We hope to build on these relationships going forward.

We deepened our relationship with patients and strengthened our efforts to support underserved and/or underrepresented populations, as well as to address rare diseases. In this report, we profile our new Sex- and Gender-Based Analysis Plus Action Plan which is designed to help those who live in Canada make informed decisions regarding treatment options that are based on safety and efficacy profiles of people like them.

This report describes the new health products Health Canada approved for sale in Canada in 2021, the information we published about these products, and how we continued to monitor approved products once on the Canadian market. It also speaks to our efforts to continuously improve our work, ensure that our regulatory system is agile and responsive to innovation, and maintain our rigorous safety standards.

For information on our activities, we invite you to follow @GovCanHealth on Twitter to learn about newly approved drugs and medical devices.

The second year of a pandemic demanded much from Health Canada in its regulatory work: resilience, endurance and persistence.

As days turned into weeks, weeks into months, and now months into years, those at the forefront of making and supporting important decisions on access to COVID-19 tests, treatments and vaccines found themselves continuing to work “flat out.” Although we are not personally at the front lines of the health care system, the products that we regulate play a crucial role in every moment of care offered to Canadians.

Waves of the pandemic brought increased demands on energy and resources for key time-sensitive decisions, and once those were completed, the resilience to quickly move onto the next critical task at hand. This of course was set against the backdrop of the challenges that we all were collectively facing outside of work, as well.

Sustaining that level of effort over the long run requires endurance. For COVID-19 health products, the volume of work, the long days necessary to support international collaboration and attention to detail that would be scrutinized to the highest degree were part and parcel of our day-to-day work. Likewise, maintaining standards for non-COVID-related products that are equally important in helping to improve and maintain the health of Canadians meant that reviews and assessments continued to be completed within committed timelines.

Lastly, communicating our work necessitated a great deal of persistence. Continuing the journey along the path of greater openness and transparency required consistent and clear messaging on all decisions. Cutting through the reams of information and often misinformation is still challenging, but we all recognize that accurate and reliable information is the cornerstone to informed decision-making. Undoubtedly, there will be lessons learned on how to best operate in these charged environments.

If this seems like a very personal message this year, it’s because it is. The strength and achievements of the Health Products and Food Branch of Health Canada rest with the individuals who gave their best every day to support Canadians through these challenging times.

Health Canada’s Regulatory Innovation Agenda responds directly to calls from stakeholders for more modern, agile regulations. These modernization efforts will help to strengthen the health care system by enabling access to more diverse treatment options for Canadians. In 2021, we continued to advance the five key pillars of the agenda:

• Modernizing clinical trial regulations
• Enabling Advanced Therapeutic Products
• Agile licensing for drugs
• Agile licensing for medical devices
• Mobile-first communications strategy

The COVID-19 pandemic has reinforced the importance of agile regulations to enable us to rapidly respond to extraordinary health events and accommodate innovative new products. Some of the agile regulatory tools we used during the pandemic were already a part of our modernization plans. These regulatory measures, in addition to the exceptional response from our staff, allowed us to expedite reviews of COVID-19 health products without compromising safety, efficacy and quality standards. These measures included, for example, reviewing evidence on a rolling basis as it became available, instead of waiting for completed submission packages, and using terms and conditions on product approvals to facilitate continued monitoring once the products were available to Canadians.

One of the key ways in which we were able to advance our agile regulatory response to the pandemic was through Interim Orders – one of the fastest mechanisms available to the federal government to help make health products available to address larger-scale public health emergencies. In 2021, we made sure that the regulatory flexibilities from these Interim Orders remained in place so that Canadians continued to benefit from timely access to COVID-19 health products.

Despite the demands of the pandemic, in 2021, we advanced a wide array of regulatory initiatives to update Canada’s regulatory system for health products. These included consulting on our proposed approach to modernize Canada’s clinical trial regulations, as well as publishing a Notice of Intent in the Canada Gazette on our intentions to expand the use of some key agile regulatory tools used in COVID-19 for other types of drugs and devices. We also published proposed regulations for formal consultation in the Canada Gazette, Part I, to improve the labelling of natural health products.

We look forward to continued collaboration with stakeholders and health care system partners in developing regulatory and policy changes that will contribute to the health and safety of Canadians and modernize our regulatory frameworks.