Drug and medical device highlights 2020: Drugs for human use

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• Drugs for human use: 2020 in brief
• Drugs for human use: What's new in 2020
• Drugs for human use: 2020 accomplishments
• Healthy clicks: Drugs for human use at glance
• Drugs for human use: Life-cycle

Drugs for human use: 2020 in brief

One of Health Canada's roles is to regulate drugs that can help Canadians maintain and improve their health. These include prescription and non-prescription ("over-the-counter") medicines, as well as vaccines.

The COVID-19 pandemic created an urgent need for access to safe, effective and high quality health products. Our response to the pandemic addressed critical issues related to drugs, as well as disinfectants and hand sanitizers, across product life-cycles.

Response to the COVID-19 pandemic

As part of the government's response to the pandemic, we introduced innovative and agile regulatory measures. These measures expedited the regulatory review of COVID-19 health products without compromising safety, efficacy and quality standards.

In 2020 we authorized 81 clinical trials related to drugs or vaccines for COVID-19. As a result of the pandemic, hundreds of clinical trials had to be amended in order to avoid contracting the infection through visits at trial sites. These amendments allowed for remote consent and visits, telemedicine, and different ways of dispensing and administering trial drugs. The pandemic also allowed for the decentralization of some clinical trials.

We approved two drugs to treat COVID-19, Veklury (remdesivir) and Bamlanivimab. We approved two vaccines, the Pfizer-BioNTech COVID-19 Vaccine and the COVID-19 Vaccine Moderna. As of December 31, 2020, two other vaccines and one other treatment were under review. We monitored the safety and effectiveness of health products related to COVID-19, and took action as needed. We also created the COVID-19 vaccines and treatments portal, which provides up-to-date information for consumers, health care professionals and researchers.

The regulation of hand sanitizers and disinfectants was an important part of our response to the COVID-19 pandemic. In 2020 we authorized over 4,400 new hand sanitizer products and approximately 200 new disinfectants.

For more information about our response to the COVID-19 pandemic, go to "Drugs for human use: 2020 accomplishments".

New drugs approved

Clinical trials and special access program

Surveillance

Transparency of decision making

This "Drugs for Human Use" chapter gives you more information about our work in 2020. For up-to-date information about our activities see the "Healthy clicks: Drugs for human use at a glance" section, and follow us on social media.

Drugs for human use: What's new in 2020

In 2020 Health Canada approved 84 new drugs, including 16 new biosimilars. More detail is available in the section "Approved in 2020: Drugs for human use".

Alimentary tract and metabolism

• Givlaari
• Ibsrela
• Mar-Trientine
• Rybelsus
• Trurapi^{Footnote *}
• Uceris

Antiinfectives for systemic use

• Amoxicillin Sodium and Potassium Clavulanate for Injection
• Anthim
• Bamlanivimab
• Cabenuva / Vocabria
• COVID-19 Vaccine Moderna
• Menquadfi
• Pfizer BioNTech COVID-19 Vaccine
• Veklury
• Vocarvi
• Xenlata
• Xofluza

Antineoplastic and immunomodulating agents

• Amgevita^{Footnote *}
• Avsola^{Footnote *}
• Daurismo
• Enspryng
• Gleolan
• Hulio^{Footnote *}
• Hyrimoz^{Footnote *}
• Idacio^{Footnote *}
• Inqovi
• Inrebic
• Kanjinti^{Footnote *}
• Mayzent
• Nivestym^{Footnote *}
• Nubeqa
• Nyvepria^{Footnote *}
• Odomzo
• Piqray
• Polivy
• Qinlock
• Riximyo^{Footnote *}
• Rozlytrek (two submissions)
• Ruxience^{Footnote *}
• Sarclisa
• Tukysa
• Verity-BCG
• Zeposia
• Ziextenzo^{Footnote *}

Blood and blood forming organs

• Addnutriv
• Bivalirudin Injection
• Cablivi
• Essepna
• Inclunox, Inclunox HP^{Footnote *}
• Noromby, Noromby HP^{Footnote *}
• Reblozyl
• Redesca, Redesca HP^{Footnote *}
• Regiocit
• Tavalisse

Cardiovascular system

• Corzyna

Dermatologicals

• Duobrii
• Teva-Betamethasone/ Calcipotriol

Genito urinary system and sex hormones

• Bijuva
• Imvexxy
• Nexplanon

Musculo-skeletal system

• Zolgensma

Nervous system

• Ajovy
• Dayvigo
• Firdapse
• Kynmobi
• Perseris
• Peyona
• Ruzurgi
• Spravato
• Suvexx
• Tomvi
• Vyndaqel

Respiratory system

• Atectura Breezhaler
• Enerzair Breezhaler

Sensory organs

• Beovu
• Luxturna

Systemic hormonal preparations, excluding sex hormones and insulins

• Increlex
• Osnuvo^{Footnote *}
• Tirosint

Various

• Galliapharm
• Itulatek
• Sani-Cide EX3
• Sodium Pertechnetate ^99mTc Injection

Drugs for human use: 2020 accomplishments

Responding to the COVID-19 pandemic

The COVID-19 pandemic has had a profound impact on the health and well-being of Canadians. It has created an unprecedented demand on Canada's health care system and has led to an urgent need for access to health products.

Health Canada's response to the pandemic addressed critical issues related to drugs for human use across product life-cycles, from clinical trials to authorizations of drugs to surveillance.

Clinical trials

In May 2020, the Minister of Health signed the Interim Order Respecting Clinical Trials for Medical Devices and Drugs related to COVID-19. This temporary measure facilitated a more efficient and flexible authorization process for clinical trials in Canada, allowing broader types of COVID-19 clinical trials to take place more efficiently. It offered greater patient access to potential COVID-19 drugs, while upholding strong patient safety requirements.

In addition, we expedited the authorization of trials for COVID-19 and published a Notice on the management of clinical trials during the pandemic. Applications were reviewed faster than usual, to speed up access without compromising patient safety. We worked with companies, academic research centres and investigators who had products in development, to provide guidance and help bring clinical trials to Canada.

In 2020 we authorized 81 clinical trials related to drugs or vaccines for COVID-19.

For more information, go to Drugs and vaccines for COVID-19: Clinical trials for drugs and vaccines.

Special Access Program

The Special Access Program is for health care professionals who are treating seriously ill patients where conventional therapies have failed, are unsuitable or are unavailable. The Special Access Program worked to help resolve critical shortages within the health care system during the pandemic. In addition, in 2020 we modernized the regulations for the program by improving processes used by health care providers and by reducing the administrative burden for requests. These changes will facilitate access to non-marketed drugs for Canadians, for COVID-19 and other medical emergencies.

For more information, go to Health Canada's special access programs: Overview.

Drugs and vaccines

Drugs and vaccines will play an essential role in Canadians' ability to recover safely from the COVID-19 pandemic.

As part of the government's response to the pandemic, Health Canada introduced innovative and agile regulatory measures. These allowed us to expedite the regulatory review of COVID-19 drugs and vaccines, without compromising our high standards for safety, efficacy and quality.

For more information on the Interim Orders that were published to address the COVID-19 pandemic, go to "Message from the Chief Regulatory Officer".

In 2020 we approved two vaccines under the Interim Order Respecting the Importation, Sale and Advertising of Drugs for Use in Relation to COVID-19, the Pfizer-BioNTech COVID-19 Vaccine and the COVID-19 Vaccine Moderna. We also approved two drugs to treat COVID-19, Veklury and Bamlanivimab. As of December 31, 2020, two other vaccines and one other treatment were under review.

We will closely monitor the use of these products in the real world, evaluate potential safety and effectiveness issues and take action where there are identified problems.

Disinfectants and hand sanitizers

The COVID-19 pandemic created an urgent need for disinfectants and hand sanitizers. These products were an important part of Health Canada's response to the pandemic to prevent the spread of COVID-19. To increase supply and ensure Canadians have access to these products, our work included:

• expediting the review of disinfectants and hand sanitizers,
• introducing interim measures such as:
  • allowing the importation of products that may not fully meet regulatory requirements, but do not compromise the safety of Canadians, to expedite access to disinfectants and hand sanitizers to address product shortages
  • temporarily authorizing technical grade ethanol in the production of disinfectants and hand sanitizers to address an identified shortage of pharmaceutical-grade ethanol,
• providing guidance on obtaining a licence to sell alcohol- and non-alcohol-based sanitizers, on producing ethanol and isopropyl alcohol to make sure the alcohol used was safe, and on obtaining an authorization to manufacture and sell disinfectants,
• working with companies who entered the hand sanitizer market, such as distilleries, to help them navigate our regulations to manufacture and sell their new products, and
• working with the disinfectant industry to inform Canadians of products that can be used to help against the spread of COVID-19.

In 2020 we authorized over 4,400 hand sanitizer products and approximately 200 disinfectants. We also developed an online list of hard-surface disinfectants with evidence for use against COVID-19, which included over 500 products as of December 31, 2020.

For more information, go to Hard-surface disinfectants and hand sanitizers (COVID-19).

Surveillance of COVID-19 health products

We monitored the safety and effectiveness of health products related to COVID-19, and took action as needed to protect Canadians.

Our work on drugs and vaccines included:

• working with the Public Health Agency of Canada to continuously monitor COVID-19 vaccines on the market in Canada,
• taking proactive steps to identify adverse events from drugs and vaccines used for COVID-19 (products explicitly approved for use in COVID-19 as well as those that were being used "off-label", or outside of the approved use of the product),
• monitoring retailers and advertisements that were making false, misleading and illegal claims related to COVID-19,
• publishing risk communications about potential safety and effectiveness concerns, and
• working closely with international partners to monitor the safety and effectiveness of COVID-19 treatments in the real world.

Our work on disinfectants and hand sanitizers included:

• monitoring the safety of disinfectants and hand sanitizers on the market in Canada,
• monitoring retailers and advertisements that were making false, misleading and illegal claims related to COVID-19, and
• publishing risk communications on safety concerns associated with disinfectants and hand sanitizers.

Drug shortages

Early in the pandemic, it was clear that COVID-19 was having an impact on the supply of critical health products in Canada. We worked with our partners within Health Canada to introduce regulatory measures that provided more tools to urgently address drug shortages related to COVID-19. We also worked with provinces and territories, companies and manufacturers, health care providers and patient groups to strengthen the drug supply chain. These collaborations helped us to identify, prevent and ease shortages for Canadians.

For more information, go to Addressing critical product shortages.

Communications and collaborations

Throughout the pandemic, Health Canada published a number of web pages to provide information to Canadians and regulatory partners. Our web pages provide information about the various health products we regulate, including clinical trials authorized, applications for drugs that have been submitted and approved, disinfectants and hand sanitizers that have been authorized, and more.

We also published web pages that provided critical information to the health product industry about our regulation of health products for COVID-19. We developed guidance to support industry in developing health products to help in the crisis.

Health Canada also published a number of risk communications to Canadians to provide important information about drugs for human use, disinfectants and hand sanitizers.

We worked closely with our domestic partners including provincial and territorial governments, health technology assessment organizations, health care providers and patient groups. We sought their perspectives on the priorities and challenges they were facing within the health care system as a result of the pandemic. Through webinars, we were able to share information with health care practitioners about important topics such as the regulatory approval of treatments for COVID-19.

We collaborated with regulators from other countries on issues related to clinical trials, drug review, risk assessments and potential drug shortages. This sharing of information and expertise helped ensure that health products are safe and effective, and are available quickly to Canadians. This is taking place as part of the European Medicines Agency's OPEN project and through the Access Consortium. We also worked closely with the International Coalition for Medicines Regulatory Authorities, the World Health Organization and the Pan American Health Organization's COVID-19 task group. These partnerships have helped us to align our approach with the global response to COVID-19.

We began 2021 in the midst of the second wave of the pandemic. We will continue this critical work to ensure Canadians continue to have access to COVID-19-related health products.

Regulatory innovation

The current pace of innovation is unprecedented. This has led to new health products that are increasingly complex and personalized. We need new regulatory approaches to better support access to these health technologies, while continuing to protect patient safety.

Health Canada continued to prioritize regulatory innovation in 2020. The COVID-19 pandemic affected the timelines of this work. However, it also provided an opportunity to test certain temporary agile measures. We will be using the lessons learned from our regulatory response to COVID-19 to inform our regulatory innovation work, including:

• modernizing clinical trial regulations to create an environment that supports more innovative trials,
• enabling access to advanced therapeutic products that do not fit our current system,
• agile licensing for drugs, using flexible tools to oversee products across their life-cycle, and
• updating how we communicate to Canadians about health product information.

For more information, go to Regulatory innovation for health products.

Building international partnerships

For many years, Health Canada has worked closely with regulators around the world on issues related to drugs. This cooperation continued in 2020, both on COVID-19-related files (see "Drugs for human use: 2020 accomplishments – Responding to the COVID-19 pandemic") and in our day-to-day work.

For example, we have built on the collaborative review initiatives between Health Canada and other regulators. These include the Access Consortium and Project Orbis. Through the Access Consortium, we work with partners to review new drugs together, to get them to market quickly and efficiently. Project Orbis is an initiative of the United States Food and Drug Administration Oncology Center of Excellence. Project Orbis brings together regulators from multiple countries to review cancer drugs at the same time so that patients can receive earlier access to needed treatments.

Through these key work-sharing initiatives, we authorized a number of new drugs and new uses for already-approved drugs in 2020. Two examples of new drugs include Nubeqa for the treatment of prostate cancer, and Xofluza for the treatment of influenza.

By sharing information and expertise with other regulators, we have also optimized our understanding of how drugs are being used after they are available for sale. This information is called "real world evidence" and is used by Health Canada and other regulators to make regulatory decisions about drugs.

We updated our agreements with various regulators including the European Union's European Medicines Agency, the United Kingdom's Medicines and Healthcare products Regulatory Agency and the Health Science Authority of Singapore. These agreements allow regulators to share information about drug submissions, and helped us further align our approaches with our global partners.

Mandatory reporting of serious adverse drug reaction by hospitals

In 2020 Health Canada supported the implementation of new regulations for mandatory reporting by hospitals that came into force in December 2019. These regulations are expected to increase the quantity and improve the quality of reports of serious adverse drug reactions. Hospitals are now required to report to Health Canada all serious adverse drug reactions 30 days from being documented within the hospital.

Health Canada developed tools to support hospitals including a guidance document, education modules and promotional materials.

The number of adverse drug reaction reports submitted to Health Canada by hospitals for drugs increased by 336 percent in 2020. After the implementation of mandatory reporting, several data elements in the report form became mandatory to ensure that important details were provided to Health Canada. This additional information aims to expand the data used by Health Canada to monitor the safety and effectiveness of drugs for human use.

Addressing antimicrobial resistance

Antimicrobials, such as antibiotics and antifungals, are essential to modern health care. However, the widespread use of these products over past decades has resulted in increasing levels of antimicrobial resistance. Commonly used antimicrobials become less effective as the pathogens they target (bacteria, viruses, fungi and parasites) become resistant to them.

Antimicrobial resistance is a global challenge and a growing threat to public health, the health care system, economic prosperity and health security. When there are fewer effective antimicrobials available, it will be harder to protect Canadians from common infectious diseases. The COVID-19 pandemic provides a clear example of the challenges created by infections that are difficult to treat.

Health Canada continues to take important steps to encourage the development of new and innovative therapeutic products, to help combat antimicrobial resistance.

In 2020 we launched a consultation on updates to the Pathogens of Interest List, inviting feedback from a wide range of stakeholders. This list is an important tool that lets companies know which pathogens are in most urgent need of additional therapeutic options. The list is having an impact; this year we approved Xenleta for the treatment of community-acquired pneumonia. Xenleta was granted priority review status because it targets difficult-to-treat pathogens on our Pathogens of Interest List.

Also in 2020, Health Canada provided funding to four companies that were successful in the first phase of the Innovative Solutions Canada challenge that was launched in 2019. This funding supports the development of novel tools so that health care providers can detect or diagnose antibiotic-resistant bacteria in humans or animals. These tools will aid in decision making about possible treatments.

We continue to work closely with regulators from other countries, including through the International Coalition of Medicines Regulatory Authorities. This Coalition has called on global health leaders to develop incentives for research and development, the pharmaceutical industry to continue to invest in research and development, and the media to keep the issue of antimicrobial resistance on the front page.

To learn about antimicrobial resistance related to animals and veterinary drugs, go to "Drugs for veterinary use: 2020 accomplishments".

Drugs for use in children

Children are different from adults, in their physiology and their anatomy. Therefore, they can respond differently to health products. Medicines need to be studied in pediatric populations to ensure that they are safe and effective. However, these studies are complex and challenging. Currently, up to 80% of drugs prescribed to children in Canada are considered "off-label", which means outside of the approved use of the drug.

To address these challenges, in 2020 Health Canada established the Pediatric Drug Action Plan. The goal of the plan is to improve children's access to safe and effective health products.

Early work on the plan has begun, and activities include:

• Collaborating with regulators around the world, including the European Medicines Agency, the United States Food and Drug Administration, and the World Health Organization. These collaborations help to strengthen our pediatric expertise and align our activities.
• Working with the Goodman Pediatric Formulation Centre of the Centre hospitalier universitaire Sainte-Justine to improve access to pediatric formulations in Canada.
• Analyzing ways to encourage companies to test health products in pediatric populations, when appropriate, and submit pediatric data to Health Canada.
• Developing a Canadian pediatric data strategy to analyse the availability of health products for use in children, trends in pediatric trials and drug safety issues associated with pediatrics.

Non-prescription drugs

Health Canada is responsible for the review of non-prescription drugs, also known as "over-the-counter" products, to ensure that they are safe, effective and of high quality. These products include, but are not limited to:

• antiseptics,
• pain relievers,
• cold and cough medicines,
• sunscreens, and
• hard surface disinfectants.

The nature of our review of non-prescription drugs depends on a number of factors. These include the ingredients, the health claims and the evidence that is needed to support the safety, efficacy and quality of the product. Health Canada issues a Drug Identification Number (DIN) to every approved non-prescription drug. Canadians should look for this number on the product label, which indicates that the drug has met our requirements.

Presently, products that contain a phytocannabinoid produced by or found in the cannabis plant can only be prescribed by a health care practitioner for medicinal purposes. We are aware that some Canadians are interested in potential therapeutic uses of cannabis for purposes such as pain relief, without the need for practitioner oversight (that is, in "over-the-counter" products). In 2019 Health Canada consulted on the potential market for such health products. We published a summary report in 2020, which provides an overview of the comments received from Canadians.

As part of this consultation, we also established a Scientific Advisory Committee on Health Products Containing Cannabis. This committee will provide us with independent scientific and clinical advice about appropriate safety, efficacy and quality considerations for health products containing cannabis. Health Canada will use this information to inform its regulatory path forward on these products.

Healthy clicks: Drugs for human use at glance

To stay informed about our activities:

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You can also find specific information about drugs by following the links below.

Drugs and vaccines for use in COVID-19

New drugs approved

Drug shortages

Clinical trails for drugs

Surveillance of drugs

Report an adverse drug reaction

Canada Vigilance Program

You can report adverse drug reactions to your medical professional, to a hospital or to the company that made the product. You can also report them to Health Canada through the Canada Vigilance Program or by phone at 1-866-234-2345.

Drugs for human use: Life-cycle

As part of Health Canada's mission to help Canadians maintain and improve their health, we evaluate drugs before they reach the Canadian market and continue to monitor real world evidence while they are on the market. Health Canada is involved throughout the life-cycle of a drug for human use, from clinical trials to after the drug is being sold in Canada.

Clinical trials

Clinical trials are conducted by sponsors (manufacturers or researchers) to gather information on a drug's safety and effectiveness in humans. Sponsors of clinical trials submit their applications to conduct a clinical trial with a drug in Canada. Health Canada reviews these applications before the trial is conducted in Canada.

Special access program

Drugs that are not approved in Canada may be available through our Special Access Program. In this program, access is given to an individual health care practitioner who is treating a specific patient. Access may be granted for emergency use, or to patients with serious or life-threatening conditions when conventional therapies have failed, are unavailable or are unsuitable.

Drug submission and review

When a company decides that it would like to market a drug in Canada, it files a submission with Health Canada. A new drug submission contains detailed scientific information about the drug's safety, quality and efficacy.

Our scientists and medical officers perform a thorough review of the information submitted. Sometimes we also consult with advisory committees or external consultants. Reviewers evaluate the safety, efficacy and quality data to assess the benefits and potential risks of the drug. They also review the information that will be provided to health care practitioners and consumers about the drug.

Expedited review pathways

We have several review processes that can provide an expedited path for certain drugs, including those that target specific health care needs. That is, there are several review pathways that have shorter review targets for certain drugs. Products approved through expedited review pathways can be available to patients sooner.

Priority review: Drugs for serious, life-threatening, or severely debilitating diseases or conditions can be given a priority review status. Drug submissions that are granted priority review status are subject to an expedited review process.

Notice of Compliance with conditions: When a new drug is approved it is issued a Notice of Compliance (NOC). A Notice of Compliance may be issued with conditions (NOC/c) to a drug that showed promising clinical benefit, for serious, life-threatening, or severely debilitating diseases or conditions. The manufacturer must still demonstrate that the drug has an acceptable safety profile and is of high quality, and also commits to undertake additional studies to verify the clinical benefit of the drug. Submissions that are reviewed under this pathway are subject to an expedited review process.

Approval of drugs

After its review of a drug submission, Health Canada may conclude that the benefits of the product outweigh the potential risks and approve the drug for sale in Canada. When a new drug is approved, it is issued a Notice of Compliance (NOC) and a Drug Identification Number (DIN). This does not mean the drug will immediately be available to patients, as many other factors can influence that timeline.

Surveillance

It is not possible to know or predict all of the possible adverse reactions to a drug through clinical studies. After a product is approved and available for sale in Canada, we continue to monitor its use in the real world, that is, in the broader Canadian population that may be taking other medications. We evaluate potential safety and effectiveness issues, and take action when there are identified problems.

Collecting information

Health Canada collects safety information about a product after it is approved from a variety of sources. One source of information is suspected adverse reactions that are reported after products are approved for sale. Adverse reactions are undesirable effects potentially caused by drugs.

Another source of information are documents called Risk Management Plans that are submitted by manufacturers as part of their drug submissions. A Risk Management Plan includes information on a drug's safety profile and how its risks will be prevented or minimized. It also contains plans for studies and other activities to learn more about the safety and effectiveness of the drug.

Evaluating safety signals

Health Canada evaluates the data we collect to detect new safety signals, which we then investigate more closely. A "safety signal" can be defined as information on a new or known adverse event that may be associated with a drug. These investigations are called signal assessments and they may result in recommendations for actions to be taken by the company, by Health Canada, or both. These actions can include informing the public and health care professionals of new safety information or recommending labelling changes. In the most serious situations, we may remove a drug from the market.

Advertising complaints

Health Canada also regulates the advertising of drugs in Canada to ensure that companies are not making false claims about their products. We review advertising complaints to determine if a company is complying with our requirements, and we take appropriate action when non-compliance is identified. This may include requesting a company to stop disseminating non-compliant advertising and taking steps towards avoiding any future issues.

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