Drug and medical device highlights 2019: Helping you maintain and improve your health

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Organization: Health Canada

Type: Publication

Published: 2020-05-28

Learn about the new drugs and medical devices that Health Canada approved for sale in Canada, the information we published about potential safety issues, and our other accomplishments in 2019.

Table of contents

Welcome to our 2019 highlights report

Health Canada helps Canadians maintain and improve their health by providing timely access to safe and effective drugs and medical devices.

In 2019 we welcomed our new Minister, the Honourable Patty Hajdu, to the health portfolio. The Prime Minister's mandate letter to our Minister outlines Health Canada's key priorities to safeguard and improve the health and safety of Canadians.

This year we focussed on two important dimensions of our work, regulatory innovation and international collaboration, to help give Canadians access to new and innovative products. We also continued to improve transparency and reduce administrative burden, while maintaining our high standards of safety, efficacy and quality.

The work we do contributes to improved healthcare outcomes for Canadians. We hope that our annual Highlights report will give you a better understanding of our priorities, and help you learn more about the drugs and medical devices we approved in 2019.

This report describes the new drugs and medical devices that Health Canada approved for sale in Canada, the information we published about potential safety issues and our other accomplishments in 2019.

As with previous years, the Highlights report is divided into three chapters: drugs for human use, medical devices and drugs for veterinary use. This year we have added a "What's New in 2019" section to each chapter, which highlights our key product approvals over the year.

Throughout the report you will also find new "Focus on…" features. These provide a closer look into our scientific work and our international collaboration, and key examples of our work on product safety.

This report provides an overview of our work in 2019. For the most up-to-date information on our activities, see the "Healthy Clicks" sections. We also invite you to follow @GovCanHealth on Twitter to learn about newly approved drugs and medical devices.

Pierre Sabourin,
Assistant Deputy Minister,
Health Canada

Kendal Weber,
Associate Assistant Deputy Minister,
Health Canada

Message from the Chief Medical Advisor

"The only thing that is constant is change". This was as true when Heraclitus, the ancient Greek philosopher, uttered it as it is now.

Science and technology continue to evolve, bringing change to the way we live and the world around us.  New therapies such as telehealth devices, 3D printing, gene therapies and health products that use artificial intelligence are entering the global market at an advanced pace. These bring benefits to patients, but also challenges to regulatory organizations like Health Canada. These smart technologies continue to inspire our transformation efforts to ensure that we are ready for the future.

This past year brought forth many innovative products that will help Canadians maintain and improve their health. For example, Health Canada evaluated new medications that are unlike any other approved antibiotics, providing treatment options for hospitalized and critically ill patients with resistant infections. This past year also brought the approval of paradigm-changing cancer treatments that are based on the unique genetic makeup of an individual's tumour, regardless of where in the body it first started. Enabling the use of these treatments means that the health system, including the role of the regulator, must evolve as rapidly as the scientific advancements that give rise to them.

The health system is also evolving. For example, in 2019 we approved several new pediatric formulations for our youngest, and often most vulnerable, Canadians. These formulations mean that healthcare professionals no longer have to rely on the longstanding practice of using medicines approved for adults.

Some challenges to the health system, such as the opioid crisis, are being met with government-wide initiatives. In addition to our work on labelling and warnings for opioids, over the past year we focussed on restricting the marketing and advertising of these medications to ensure that they are used appropriately.

Health Canada recognizes that the challenges we face are not unique to our country. Our efforts such as the modernization of the way we oversee clinical trials and the creation of new pathways to assess novel innovative therapies for Canadians are enriched by the collaboration we have with international colleagues. Health Canada has built strong relationships with regulators worldwide to advance collaboration in our work on new safety standards, and to lead efforts in assessing new innovative products. Sharing work with other regulators maximizes our collective expertise and avoids duplication of effort. For example, collaboration with Australia resulted in the approval of two new anti-cancer drugs in 2019.

The pace of change will only get faster from here. Our efforts to respond to innovation in this interconnected world will prepare us well for the road that lies ahead.

Supriya Sharma,
Chief Medical Advisor,
Health Canada

Message from the Chief Regulatory Officer

Canadian laws and regulations underpin the work we do to protect the health and safety of Canadians. Health Canada's regulations enable us to:

In 2019 we made improvements to the Food and Drugs Act to make sure that Canadians can benefit from new research approaches and highly advanced types of therapeutic products. We proposed an Advanced Therapeutic Products pathway so that we can tailor our regulatory approach for certain products, such as those that rely on artificial intelligence, 3D bio-printing or types of cell technology. We also introduced more efficient and up-to-date ways to regulate clinical trials and classify types of products.

We implemented new regulations to increase our ability to monitor the safety of drugs and medical devices, and provide Canadians more information. Together, these regulations will help Canadians make well-informed decisions about the health products they use.

We have also published regulations under the Assisted Human Reproduction Act that will support Canadians who use assisted human reproduction to safely build their families. We strengthened safety standards and now offer the LGBTQ2+ community and single-intended parents more flexibility in building their families through the directed donation process.

In the coming months, we will keep working on modernizing health product regulation for Canadians. We will continue our discussions with stakeholders to ensure our new regulations support innovation and protect Canadians.

David K. Lee,
Chief Regulatory Officer,
Health Canada

Drugs for human use

Drugs for human use: 2019 in brief

Safe, effective and high quality drugs can help Canadians maintain and improve their health. These include vaccines, as well as prescription and non-prescription ("over-the-counter") medicines.

Health Canada evaluates and monitors the benefits and risks of drugs throughout their life cycle, to make sure that the benefits outweigh the potential risks. This is the core of our work.

However, the world in which we work is changing rapidly and so are the drugs we regulate. We must keep pace with advances in science and technology. Two of our key priorities in 2019 focus on these challenges:

The "Drugs for human use: 2019 accomplishments" section describes our progress in these and other areas.

New drugs approved

In 2019 we approved 58 new drugs. These give patients more options for the treatment, prevention and diagnosis of various health conditions.

Thirty-five of the new drugs we approved in 2019 contained medicinal ingredients that have never been approved for sale in Canada, what we call "new active substances". Thirty-four percent of these were approved through an expedited pathway, including those that target specific healthcare needs.

It is also important to bring more choice and more affordable options to Canadians. We approved 129 new generic drugs and 5 new biosimilars in 2019.

In 2019 Health Canada approved four new non-prescription ("over-the-counter") drugs, offering more options to Canadians for treating and managing symptoms of minor ailments.

For a list and description of the new drugs we approved in 2019, go to "Drugs for human use: Approved in 2019". In this section you will also learn how we addressed safety issues that arose for drugs in Canada.

Clinical trials and Special Access Programme

We review applications to allow companies and researchers to conduct clinical trials in Canada. New clinical trials mean Canadians may have access to more innovative treatment options. In 2019, 1089 new clinical trial applications for drugs were approved. Several involved complex, novel, adaptive clinical trial designs, and some trials will facilitate participation of Canadians living in remote areas.

Through our Special Access Programme, we give access to drugs that are not available in Canada. We may grant access to doctors for emergency use or for the treatment of serious or life-threatening conditions. In 2019, 12,314 requests for special access to drugs were authorized. This included drugs for children and drugs for serious infections, as well as cancer treatments.

Surveillance

After we approve a drug for sale in Canada, we continue to monitor and evaluate reports of suspected adverse reactions.

In 2019 we received 1,131,148 reports of adverse reactions to drugs for human use. These come from domestic and international sources. We undertook 1,162 actions related to drugs. These actions can include informing the public and healthcare professionals of new safety information or recommending labelling changes. In the most serious situations, we may remove a drug from the market.

This "Drugs for Human Use" chapter gives you more information about our work in 2019. 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.

John Patrick Stewart,
Director General,
Therapeutic Products,
Health Canada

Celia Lourenco,
Director General,
Biologics and Genetic Therapies,
Health Canada

Manon Bombardier,
Director General,
Non-Prescription Drugs,
Health Canada

Marc Mes,
Director General,
Marketed Health Products,
Health Canada

Drugs for human use: What's new in 2019

In 2019 Health Canada approved 58 new drugs, including 5 new biosimilars. More detail is available in the section "Drugs for human use: Approved in 2019".

Alimentary tract and metabolism

Antiinfectives for systemic use

Antineoplastic and immunomodulating agents

Blood and blood forming organs

Cardiovascular system

Dermatologicals

Genito urinary system and sex hormones

Musculo-skeletal system

Nervous system

Respiratory system

Sensory organs

Systemic hormonal preparations, excluding sex hormones and insulins

Various

Drugs for human use: 2019 accomplishments

Regulating innovative drugs

Scientific and technological advances have led to new ways to diagnose, treat and monitor patients. For example, technologies like gene editing mean that products can be personalized to an individual patient.

In 2019 Health Canada announced it would develop new regulations that are agile and that will support innovative new therapies. Health Canada met with key stakeholders across the country and around the world to better understand the changes we are seeing. We also discussed the challenges that stakeholders face in bringing innovative new products to market. Health Canada published a "What we heard" document that describes the key findings from these discussions.

As part of our ongoing Regulatory Innovation initiative, we are focussing on how we oversee clinical trials, approve complex new therapies and use foreign reviews and decisions.

Changing how we regulate clinical trials

Clinical trials are usually the first step in developing new drugs. As products evolve, so do clinical trials. We need clinical trial regulations that are more flexible so that new drugs can be developed and tested. The level of oversight should be based on the potential risk of the trial.

Health Canada will put in place regulations to allow for new types and designs of clinical trials. For example, people who live in remote areas may be able to participate in trials through the use of virtual technology. This approach will improve our alignment with regulators around the world. It will also encourage more sponsors to conduct clinical trials in Canada.

Creating a flexible approach for approving complex new therapeutic products

Some therapeutic products are so novel, complex and distinct that they do not fit within our current regulations. We need a way to approve these products that is flexible and based on their potential risk.

Health Canada is proposing a new pathway for these "Advanced Therapeutic Products". Using this pathway, we will collaborate with stakeholders to create regulatory requirements that can be tailored to a specific product. It will allow us to manage these products throughout their life cycle, and still maintain our high standards for patient safety.

Using foreign reviews and decisions

Health Canada has a process in place where we may use information provided by other regulatory agencies. We are now looking into ways we can build on this, to help increase access to drugs for Canadians. Health Canada is also exploring opportunities to share work with our international partners according to our respective expertise.

We are also exploring using decisions of certain regulators to approve certain drugs that would meet an unmet medical need. For example, this could help bring some drugs that are currently accessed through the Special Access Programme to the broader Canadian market.

We know that it is important for Health Canada to be at the forefront of innovation. We will maintain, and invest in, our core business of reviewing innovative and generic drugs to protect the health and safety of Canadians. Our discussions with our stakeholders will continue as we develop our regulations, to make sure the regulations will respond to new science and technology and to the needs of Canadians.

Focus on … regulatory innovation

"This is a turning point for health product regulation as we work to ensure our regulations and programs adapt to the changing landscape of health product innovation. It is essential that the work we do protects the safety of Canadians and enables innovation to improve their health."

Elizabeth Toller,
Executive Director,
Regulatory Innovation,
Health Canada

Building international partnerships

Health Canada has a long history of working with regulators around the world. This co-operation ranges from ad-hoc meetings about global drug safety issues, to work with international organizations to harmonize our requirements for drugs.

We come together to combine our expertise, develop policies and set standards. Strong relationships with other countries help us all address health risks more effectively. In addition, working together helps us all support timely access to safe new drugs.

Some examples of our collaborations with other regulators in 2019 included:

Focus on … international collaboration

"The EMA and Health Canada will work further together in the future and we will continue to collaborate on key issues. We want to understand how you are operating and how we can benefit from the work you have done. Building collaboration with Canada is important to us and we need to structure our relationship more."

Professor Guido Rasi,
Executive Director,
European Medicines Agency (EMA)

Focus on … international collaboration

"Project Orbis was a unique opportunity to collaborate with our international partners that enabled early access to a new treatment for a disease with an unmet medical need. The aligned review allowed for real-time insights into the FDA review approach, analysis, and interpretation of data common to that submitted to Health Canada. It was certainly a productive learning experience that will help us improve our own processes and facilitate further projects with our international counterparts."

Dr. Jian Wang,
Division Manager,
Health Canada

Dr. Bradley Scott,
Senior Clinical Evaluator,
Health Canada

Dr. Jaigi Mathai,
Senior Clinical Evaluator,
Health Canada

Dr. Maxime Sasseville,
Manager,
Health Canada

Focus on … international collaboration to improve drug safety

In 2017 a Canadian case was reported of a patient who had taken an anti-cancer drug and then developed a tear in an artery wall. Health Canada reviewed the potential risks of these types of products and found there may be a link between their use and structural changes to the walls of arteries. The products are called "vascular endothelial growth factor receptor tyrosine kinase inhibitors (VEGFR TKIs)" and they are approved in Canada for the treatment of various types of cancer. In 2019 Health Canada and the European Medicines Agency shared information and reviews, and both regulators put in place measures to help reduce the risk associated with the products. In Canada, we are working with manufacturers to update the product safety information for all VEGFR TKIs so that patients and healthcare professionals are informed of the risk.

Focus on … Medication Safety Week, November 25-29, 2019

Every year during Medication Safety Week, international regulators work together through ICMRA to promote awareness about adverse drug reactions. To coincide with Medication Safety Week, Health Canada launched a series of social media messages to help encourage reporting of adverse drug reactions.

Publishing clinical information about drugs for human use

"Clinical information" is data about the safety and efficacy of a drug, and includes information about the design and results of clinical trials. In 2019 Health Canada began publishing the clinical information that is provided by companies when they seek approval to sell a drug in Canada. The clinical information is made available after Health Canada has finished its review and has made a decision about approving or rejecting a drug.

Providing public access to this clinical information will benefit Canadians by:

We make clinical information available through our "Clinical Information Portal". In 2019 we published 455,129 pages of clinical information on 21 drugs.

For more information, go to "Clinical information on drugs and health products".

Mandatory reporting of serious adverse drug reactions

Health Canada continues to look for ways to strengthen our knowledge about the safety of drugs on the Canadian market. Reports of adverse drug reactions (ADRs) help us identify emerging safety issues. However, we know that ADRs are under-reported around the world. In addition, the reports that are submitted can be missing important information.

To help address these issues, in 2019 Health Canada published final regulations that aim to increase the quantity and improve the quality of reports of serious ADRs. Hospitals are now required to report to Health Canada all serious ADRs, whether the ADR took place in the hospital or before a patient went to the hospital.

To help hospitals implement this change, Health Canada helped to develop educational materials and online tools to make it easier to submit reports.

The additional, higher quality data will help Health Canada improve the safety of drugs by:

Using real world evidence

During drug development, sponsors (researchers and manufacturers) conduct clinical trials to demonstrate that a drug is safe and effective. However, it may be challenging to conduct clinical trials for certain diseases (such as rare diseases) or patient populations (such as children or pregnant women). In these cases, information about how drugs are being used after they are available for sale can help us understand how to use the drugs safely and effectively. We call this information "real world evidence".

The use of real world evidence already informs our decisions throughout the life cycle of a drug. It is used in the review of new drugs, and to monitor the safety and effectiveness of drugs once they are available for sale in Canada. The availability of real world evidence is increasing steadily worldwide.  Health Canada is working with key partners to make sure that the evidence we collect can help assess the safety and effectiveness of a drug throughout its life cycle.

Health Canada will continue to use high quality real world evidence to support our decisions, to help protect the health and safety of Canadians and to increase patient access to treatments.

Addressing the opioid crisis

The opioid crisis continues to be one of the most serious public health issues in Canada's recent history. Increasing access to treatments, as well as harm reduction options, is a key element in addressing the opioid crisis.

In 2019 Health Canada became the first country in the world to approve injectable hydromorphone in adults with severe opioid use disorder. We also added diacetylmorphine (pharmaceutical-grade heroin) to the List of Drugs for an Urgent Public Health Need, at the request of Canada's Chief Public Health Officer. This list enables medical officers of health to import drugs that are not yet available in Canada but have been approved for sale in certain other countries, to meet an urgent public health need. Diacetylmorphine can now be imported for the treatment of opioid use disorder.

This past year, we took additional steps to further restrict the marketing and advertising of prescription opioids. All promotional materials must be limited to only statements that have been approved by Health Canada in the Product Monograph. Statements have to be presented verbatim, and convey the benefits and risks of opioids in a balanced way. These measures build on already-announced initiatives to address the pharmaceutical industry's opioid marketing and advertising practices.

Regulatory review of drugs and devices

Health Canada developed the "Regulatory Review of Drugs and Devices" initiative in 2017 to provide patients with more timely access to drugs and medical devices. Other goals include increasing our work with partners in the healthcare system in Canada and with other countries, and making better use of real-world evidence (data collected outside of clinical trials) across a product's life cycle.

In 2019 Health Canada continued to achieve significant progress in support of drug access. For example, we continued to align our review processes with those of the health technology assessment organizations (Canadian Agency for Drugs and Technologies in Health [CADTH], and Institut national d'excellence en santé et services sociaux [INESSS]). This alignment helps drugs reach patients more quickly. We approved 14 new drugs with this "aligned review" process in 2019. For more information, go to "Drugs for human use: Approved in 2019".

We also launched a pilot project to provide early parallel scientific advice to companies with CADTH. This project will help companies understand the requirements of both Health Canada and its health technology assessment partners, at the same time. This work will help companies create more effective drug development plans. 

We consulted on a draft guidance document on accelerated reviews to meet healthcare system needs. This approach will help improve access to those drugs that are needed most by Canadians.

Addressing antimicrobial resistance

Antimicrobials, such as antibiotics and antivirals, are used to treat people and animals. Bacteria, viruses, fungi and parasites can resist antimicrobials. This is known as antimicrobial resistance (AMR). The misuse and over-use of antimicrobials has led to the rapid development and spread of AMR in Canada and around the world.

Antimicrobials are essential in modern health care. When they do not work as well as they should, we are less effective at treating common infectious diseases. This is a major threat to global public health, economic prosperity and security.

Health Canada continues to take important steps to encourage the development of new and innovative therapeutic products. In 2019 we approved a new use for the antibiotic drug Zerbaxa through an expedited review, because it targeted difficult-to-treat pathogens on our Pathogens of Interest List.

As part of our work with international partners, Health Canada led the development of a joint statement on AMR from ICMRA. We also issued a challenge under Innovative Solutions Canada. This challenge will fund the development of a novel tool so that health care providers can detect or diagnose antibiotic resistant bacteria in humans or animals.

To learn about antimicrobial resistance related to animals and veterinary drugs, go to "Drugs for veterinary use: 2019 accomplishments".

Focus on … AMR Awareness Week, November 18-22, 2019

Every year Health Canada, along with international health agencies, supports AMR Awareness Week. This global initiative aims to raise awareness of antimicrobial resistance and highlight best practices to help stop the spread of antibiotic resistance. To coincide with AMR Awareness Week, we launched a series of social media messages to raise awareness of this important issue as well as the joint statement on AMR that Health Canada issued with ICMRA.

Providing more cost-effective treatment options

Generic and biosimilar drugs provide additional options for more cost-effective prevention and treatment.

Generic drugs contain the same medicinal ingredients as the brand name drug, and are considered bioequivalent to the brand name drug.

In 2019 Health Canada proposed regulations and draft guidance documents to improve access to affordable generic drugs. We also continued to work on the Australia-Canada-Singapore-Switzerland (ACSS) Consortium Generic Medicines Work Sharing Trial. In this program, a submission for a generic drug is filed with multiple countries in the ACSS Consortium and the review work is shared between countries.

Biosimilars are biologic drugs that enter the market subsequent to a previously authorized drug in Canada with a demonstrated similarity to the previously authorized biologic drug.

In 2019 Health Canada provided a number of publications to support biosimilars regulation and stakeholder education. We published a Policy Statement on the Naming of Biologic Drugs. Under this policy, biologic drugs including biosimilars can be clearly identified by use of the unique brand name and non-proprietary (medicinal ingredient) name, in addition to other product-specific identifiers such as the Drug Identification Number (DIN). This naming convention supports product-specific identification of biologic drugs, including biosimilars, throughout the medication use process and in adverse drug reaction reporting.

Health Canada also updated our Biosimilar biologic drugs in Canada: Fact Sheet to provide additional information to health professionals and patients about biosimilars and their regulation in Canada. In addition, we contributed to the International Coalition of Medicines Regulatory Authorities (ICMRA) statements on biosimilars for healthcare professionals and patients and the general public. These statements give assurance that regulators have robust processes in place for the authorization and monitoring of biosimilars.

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:

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.

In 2019 Health Canada approved four new non-prescription drugs, offering more options to Canadians for treating and managing symptoms of minor ailments.

Improving the labelling of non-prescription drugs

The review of product labels is a very important component in the evaluation of non-prescription drugs. The labels are the main source of information in a self-care environment. As such, it is critical that the label provides simple information in a legible way, so that Canadians can make informed choices for themselves and their families.

In recent years, Health Canada introduced new requirements for labels so that information about non-prescription drugs is easier to read, understand and locate on the package. Our requirements include larger text size, better contrast and a greater emphasis on providing Canadians with the information they need.

In addition, for a consistent look and feel, important information about a non-prescription drug is presented in a tabular format called the Canadian Drug Facts Table.

In 2019 Health Canada approved 516 non-prescription drug submissions that met our new requirements. We expect that non-prescription drugs with these new labels will be available soon.

Focus on … safety

"It's very important that people use non-prescription drugs appropriately. Through the introduction of the Canadian Drug Facts Table, we hope to promote the safe use of medications and reduce preventable medication errors."

Jason DiMuzio,
Label Review Coordinator,
Health Canada

Focus on … our science

In 2019 our regulatory scientists studying biologic drugs published a paper titled "Remarkable Structural Diversity of N-Glycan Sulfation on Influenza Vaccines". The publication describes their analysis of the sugar-structure of the influenza vaccine. Their work will contribute to a better understanding of the influenza vaccine.

Dr. Sean Li,
Research Scientist,
Health Canada

Dr. Terry Cyr,
Research Scientist,
Health Canada

Yi-Min She,
Research Chemist,
Health Canada

Focus on … drug safety

In the summer of 2018, potentially unsafe levels of an impurity were identified in some lots of drugs containing valsartan. These impurities could be cancer causing. This prompted an investigation that resulted in a recall of affected valsartan products. In 2019 Health Canada continued to work closely with regulators worldwide to understand and address this issue. Similar impurities were found in other drugs in the "sartan" class, and later in drugs containing ranitidine. We continued to investigate the root causes and we set strict limits for the impurity. Other areas of Health Canada inspected manufacturing sites, and tested drug products in laboratories. We sent letters to manufacturers to inform them about the factors that can cause these impurities to form, and steps they should take to make sure the impurities are not present in their products.

Focus on … our science

In 2019 our regulatory scientists studying biologic drugs published a paper titled "Chitosan alters inactivated respiratory syncytial virus vaccine elicited immune responses without affecting lung histopathology in mice". Their work is focussed on the evaluation of a future vaccine against the respiratory syncytial virus. This virus infects almost all children under the age of one, and is a top priority of the World Health Organization.

Dr. Terry Cyr,
Research Scientist,
Health Canada

Dr. Simon Sauvé,
Research Scientist,
Health Canada

Dr. Sean Li,
Research Scientist,
Health Canada

Louise Larocque,
Senior Research Technologist,
Health Canada

Caroline Gravel,
Biologist,
Health Canada

Marsha Russell,
Biologist,
Health Canada

Not pictured:

Healthy clicks – Drugs for human use at a glance

To stay informed about our activities:

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

New drugs approved

Health Canada regularly tweets about new drugs approved.

The Drug and Health Product Register provides information for consumers about drugs that are currently marketed in Canada.

The Drug Product Database is a listing of all drugs approved for sale in Canada. In the database, many drugs are accompanied by their Product Monographs, which describe the conditions of use of the product.

New Search for data about the tests and trials that were performed on drugs to evaluate their safety and efficacy.

The Submissions Under Review Lists show the drugs that are currently being reviewed by Health Canada.

The Generic Submissions Under Review List shows the generic drugs that are currently being reviewed by Health Canada.

The Notice of Compliance database lists the approvals (Notices of Compliance or NOCs) issued for new drugs.

Regulatory Decision Summaries include the purpose of a drug submission and the reasons for Health Canada's decision to approve or reject it.

Summary Basis of Decision documents give the detailed regulatory, safety, effectiveness and quality considerations that factored into Health Canada's decision to approve certain drug submissions.

Drug shortages

The Drug Shortages in Canada website gives information on actual and anticipated drug shortages.

Clinical trials for drugs

The Clinical Trials Database lists the clinical trial applications that have been approved for drugs in Canada.

Surveillance of drugs

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.

The Recalls and Safety Alerts Database includes the recalls, advisories, safety alerts and other publications issued by Health Canada.

Summary Safety Reviews summarize our completed reviews of potential safety issues for drugs.

New Safety and Effectiveness Reviews are tables listing reviews that are currently ongoing in Health Canada.

Health Product InfoWatch is a monthly publication intended primarily for healthcare professionals. The Health Product InfoWatch provides clinically relevant information about health products and their safety.

The summary tables of advertising complaints list the complaints about health product advertising that have been filed with Health Canada, and the action we have taken.

The Canada Vigilance Adverse Reaction Online Database includes information about suspected adverse reactions to health products and about medical device incidents. These reports have been submitted by consumers and health professionals as well as drug manufacturers and distributors.

Medical devices

Medical devices: 2019 in brief

Safe, effective and high quality medical devices can help Canadians maintain and improve their health. Medical devices are used in the treatment, diagnosis or prevention of diseases or abnormal physical conditions.

In Canada, medical devices are categorized into four groups based on the level of risk associated with their use. These groups are called "Classes" and range from I to IV. Class I devices are considered low-risk devices – for example, a wheelchair. Class IV devices present the greatest potential risk – for example, a defibrillator.

Health Canada provides timely access to new and innovative technology, while overseeing the safety and effectiveness of the medical devices on the Canadian market.

The Medical Devices Action Plan continued to be one of our key priorities this year. The objective of the Action Plan is to strengthen the regulation of medical devices in Canada by:

In 2019 we made significant progress in meeting these goals. We expanded our scientific expertise, strengthened our monitoring of medical devices and provided more information to Canadians about the medical devices they use.

For example, we created a Scientific Advisory Committee on Health Products for Women. This committee gives voice to patient advocates, physicians and researchers on current and emerging issues relating to women's health, and the regulation of the medical devices and drugs that they use. 

The "Medical devices: 2019 accomplishments" section describes our progress this year in these and other areas.

Making safe and effective medical devices available to Canadians in a timely manner is the core of our work. In the "Medical devices: Approved in 2019" section you will learn about the new high-risk medical devices we approved, and how we addressed safety issues that arose.

New medical devices approved

In 2019 we approved 360 new medical devices in the highest risk categories (Classes III and IV).  These devices provide patients and healthcare professionals with new and innovative options for the treatment, prevention and diagnosis of various health conditions.

For a list and description of the 56 new Class IV (highest-risk) medical devices we approved in 2019, go to "Medical devices: Approved in 2019".

Investigational testing and Special Access Programme

We review applications to allow companies to conduct investigational testing on medical devices in Canada. New trials mean Canadians may have access to more innovative choices. In 2019, 144 new investigational testing applications for medical devices were approved.

Through our Special Access Programme, we give access to medical devices that have not been approved for sale in Canada. We grant access to doctors for emergency use or when alternatives are unsuitable or unavailable. In 2019, 2829 requests for special access to medical devices were authorized.

Surveillance

After we approve a medical device for sale in Canada, we continue to monitor and evaluate reports of suspected incidents involving that medical device.

In 2019 we received 43,832 reports of medical device incidents. These come from domestic and international sources. We undertook 36 actions related to medical devices. These actions can include informing the public and healthcare professionals of new safety information or recommending labelling changes. In the most serious situations, we may remove a medical device from the market.

This "Medical Devices" chapter gives you more information about our work in 2019. For up-to-date information about our activities see the "Healthy clicks – Medical devices at a glance" section, and follow us on social media.

John Patrick Stewart,
Director General,
Therapeutic Products,
Health Canada

Marc Mes,
Director General,
Marketed Health Products,
Health Canada

Medical devices: What's new in 2019

In 2019 Health Canada approved 56 new Class IV (highest-risk) medical devices. More detail is available in the section "Medical devices: Approved in 2019".

Anaesthesia and respiratory devices

Body tissue manipulation and reparation devices

Cardiovascular devices

Dental devices

Disability-assistive products

In vitro diagnostic medical devices

Neurological devices

Plastic surgery and cosmetic devices

Medical devices: 2019 accomplishments

Regulating innovative devices

Scientific and technological advances have led to new ways to diagnose, treat and monitor patients. For example, technologies like 3D printing and artificial intelligence mean that products can be personalized to an individual patient.

In 2019 Health Canada announced it would develop new regulations that are agile and that will support innovative new therapies. Health Canada met with key stakeholders across the country and around the world to better understand the changes we are seeing. We also discussed the challenges that medical device manufacturers and other stakeholders face in bringing innovative new products to market. Health Canada published a "What we heard" document that describes the key findings from these discussions.

As part of our ongoing Regulatory Innovation Initiative, we are focussing on how we oversee investigational testing and approve complex new therapies. 

Changing how we regulate investigational testing

Investigational testing is usually the first step in developing new medical devices. Health Canada is enhancing patient protection by strengthening the way clinical trials involving medical devices are conducted in Canada.

As products evolve, so do the trials that are conducted. We need regulations that are more flexible so that new medical devices can be developed and tested.

These changes will improve the safety of participants in trials and align our approach with other regulators. It will also encourage research in Canada.

Creating a flexible approach for approving complex new medical devices

Some therapeutic products are so novel, complex and distinct that they do not fit within our current regulations. We need a way to approve these types of products that is flexible and based on their potential risk.

Health Canada is proposing a new pathway for these "Advanced Therapeutic Products". Using this pathway, we will collaborate with stakeholders to create regulatory requirements that can be tailored to the specific product. It will allow us to manage these products throughout their life cycle, and still maintain our high standards for patient safety.

We know that it is important for Health Canada to be at the forefront of innovation. We will maintain, and invest in, our core business of reviewing innovative new medical devices to protect the health and safety of Canadians. Our discussions with stakeholders will continue as we develop our regulations, to make sure the regulations will respond to new science and technology and to the needs of Canadians.

Focus on … regulatory innovation

"This is a turning point for health product regulation as we work to ensure our regulations and programs adapt to the changing landscape of health product innovation. It is essential that the work we do protects the safety of Canadians and enables innovation to improve their health." - Elizabeth Toller, Executive Director, Regulatory Innovation, Health Canada

Building international partnerships

Health Canada has a long history of working with regulators around the world. This co-operation ranges from meetings about global medical device safety issues, to working with international organizations to harmonize our requirements for medical devices.

We come together to combine our expertise, develop policies and set standards. Strong relationships with other countries help us all address health risks more efficiently and effectively. In addition, working together helps us all support timely access to safe new medical devices.

International Medical Devices Regulators Forum

In 2019 Health Canada continued its work with the International Medical Devices Regulators Forum (IMDRF). This group of medical device regulators works to harmonize the regulation of medical devices. This cooperation can make innovative medical devices available to patients more quickly around the world.

This year we implemented an IMDRF guidance document that describes a common structure that companies should use when they apply for approval of a high-risk medical device.

Health Canada leads an IMDRF working group on electronic formats for medical device applications and co-chairs a working group on cybersecurity. We also participate in the IMDRF adverse events working group, which is developing a harmonized terminology for reporting incidents related to medical devices.

Canada-United States Regulatory Cooperation Council

The Canada-United States Regulatory Cooperation Council (RCC) was created to reduce unnecessary differences between the countries' regulatory frameworks. As part of this work, Health Canada and the United States Food and Drug Administration (FDA) will continue to work together on regulatory topics, particularly through the IMDRF. We are working with the FDA towards the development of the Medical Device Single Review Program (MDSRP). The MDSRP aims to improve patient access to medical devices, support innovation and strengthen the development of standards.

International Cooperation

The high quality of a medical device helps ensure that it functions as it is intended. This is particularly important for devices with long lifetimes and those that are implanted in the body. In 2019 Health Canada completed its transition to an audit system called the Medical Device Single Audit Program (MDSAP). The MDSAP was designed and developed so that one single audit is needed, that can then meet the requirements of multiple regulatory agencies around the world.

This program aligns with our partners in other countries, and continues to ensure the quality of the medical devices sold in Canada. To date more than 99% of active medical device licences have complied with this requirement.

Focus on … Medical Device Single Audit Program (MDSAP)

International partners that are participating in the MDSAP include:

MDSAP Members:

MDSAP Official Observers:

MDSAP Affiliate Members:

Medical Devices Action Plan

Health Canada's Medical Devices Action Plan is a strategy to strengthen the regulatory system for medical devices. Through the Action Plan, we aim to continuously improve the safety, effectiveness and quality of devices in Canada.

In 2019 we continued to focus on the three components of the Medical Devices Action Plan.

Improving how medical devices get on the Canadian market

We expanded our use of outside experts and improved our internal expertise. For example, Health Canada created a new Scientific Advisory Committee on Health Products for Women (SAC-HPW), which held its first two meetings in 2019. We also held meetings of the Scientific Advisory Committees on Digital Health Technologies and Medical Devices Used in the Cardiovascular System. Through these committees, we improved our internal expertise through advice from the scientific, medical and patient communities about current and emerging issues.

Focus on … expert advice

In 2019 as part of the Medical Devices Action Plan, Health Canada formed a new Scientific Advisory Committee on Health Products for Women (SAC-HPW). This committee includes members representing the patient and healthcare professional communities. This committee will provide Health Canada with advice on current and emerging issues regarding women's health. Members will examine issues across the life cycle of medical devices and drugs.

"Optimal health relies on sex and gender sensitive evidence and analysis, especially in regulating drugs and devices used primarily by women and girls. This important opportunity to advise on actions for improving the safety and monitoring of women's health products is welcome and timely, in light of increasing scrutiny on health products designed for women in particular."

Dr. Lorraine Greaves,
Chair,
Scientific Advisory Committee on Health Products for Women

Strengthening monitoring and follow-up of medical devices

Health Canada put forward two initiatives in 2019 as part of our work on the Medical Devices Action Plan. The first implemented mandatory reporting of medical device incidents by hospitals. For more information, go to "Medical devices: 2019 Accomplishments – Mandatory reporting of medical device incidents". The second proposed draft regulations for surveillance of medical devices currently available in Canada. Together, these initiatives will help us improve how we monitor and address potential safety issues.

Providing more information to Canadians

In 2019 Health Canada began publicly releasing clinical information that was submitted to Health Canada in medical device applications. For more information, go to "Medical devices: 2019 Accomplishments – Publishing clinical information about medical devices".

We also began publishing summaries of our decisions for more new medical devices and for amendments to existing higher-risk products. With this change, Health Canada will now publish over 1,000 regulatory decision summaries per year. Canadians can consult these summaries to learn more about our decisions and the medical devices they use.

In addition, we are working to launch a medical device incident database that contains reports in a user-friendly, searchable, online format.

Publishing clinical information about medical devices

"Clinical information" is data about the safety and efficacy of medical devices, and includes information about the design and results of investigational testing. In 2019 Health Canada began publishing the clinical information that is provided by companies when they seek approval to sell a medical device in Canada. The clinical information is made available after Health Canada has finished its review and has made a decision about approving or rejecting a medical device.

Providing public access to this clinical information will benefit Canadians by:

We make clinical information available through our "Clinical Information Portal". In 2019 we published 465 pages of clinical information on 8 medical devices.

For more information, go to "Clinical information on drugs and health products".

Mandatory reporting of medical device incidents

Health Canada continues to look for ways to strengthen our knowledge about the safety of medical devices on the Canadian market. Reports of medical device incidents (MDIs) help us identify emerging safety issues. However, we know that MDIs are under-reported around the world. In addition, the reports that are submitted can be missing important information.

To help address these issues, in 2019 Health Canada published final regulations that aim to increase the quantity and improve the quality of MDI reports. Hospitals are now required to report to Health Canada all MDIs for medical devices documented within the hospital.

To help hospitals implement this change, Health Canada helped to develop educational materials and online tools to make it easier for hospitals to submit reports.

The additional, higher quality data will help Health Canada improve the safety of medical devices by:

Regulatory review of drugs and devices

Health Canada developed the "Regulatory Review of Drugs and Devices" initiative in 2017 to provide patients with more timely access to drugs and medical devices. Other goals include increasing our work with partners in the healthcare system in Canada and with other countries, and making better use of real-world evidence (data collected outside of clinical trials) across a product's life cycle.

As part of this initiative, in 2019 we launched an e-Learning tool, "Understanding How Medical Devices are Regulated in Canada – Premarket Regulation". This tool is designed to provide an overview of Health Canada's premarket regulatory requirements for medical devices. It is expected to help companies improve the completeness and quality of their applications. This in turn will result in more positive, and more timely, regulatory decisions from Health Canada.

Digital health technologies

Digital health technologies are evolving quickly and can benefit Canadians. For example, artificial intelligence is helping to diagnose certain diseases and develop treatment options that are more accurate and efficient.

These innovations can make healthcare delivery more accessible, convenient and cost-effective. However, advances in medical devices pose unique challenges. Health Canada must keep pace with innovation, and also make sure these products are safe and effective.

In 2019 Health Canada continued to focus on providing access to digital health technologies. For example, we are receiving an increasing number of applications for medical devices that use artificial intelligence, such as applications that are used in the analysis of images from MRIs and CT scans.

Our new Digital Health Division continues to work with other regulators and with scientific experts in Canada and around the world. We have collaborated on topics such as machine learning and artificial intelligence, as well as cybersecurity.

Health Canada has also finalized guidance documents for industry on 3D printing and cybersecurity, and we published a guidance on software as a medical device. These documents will help clarify Health Canada's standards in these important areas.

Focus on … our science

"Medical devices that are manufactured by 3D printing can offer a personalized solution: a device designed based on the needs of an individual patient. The guidance will help our decision-making in the face of rapid advances in technology. It will also inform manufacturers of our expectations with respect to the evidence we require ensuring 3D-printed medical devices are safe and effective."

Andrea Katynski,
Scientific Evaluator,
Health Canada

Addressing safety issues

In 2019 Health Canada focussed on possible risks related to several types of medical devices. We met with patients who had received pelvic meshes for transvaginal repairs, and those with breast implants. 

Working with mesh manufacturers, Health Canada addressed concerns related to pelvic meshes by limiting their use through labelling revisions. Meshes that did not meet our safety and effectiveness requirements were removed from the Canadian market by the manufacturers.

Health Canada found that "macro-textured" breast implants had an increased risk of a type of non-Hodgkin lymphoma, a cancer that affects the immune system. Health Canada suspended the licences of the "macro-textured" implants that were available in Canada. We updated our published information about breast implants. We also published information about the safety review and the licence suspension. Health Canada continues to monitor and review all available scientific and clinical information regarding the safety of textured breast implants.

Healthy clicks – Medical devices at a glance

To stay informed about our activities:

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

New medical devices approved

Health Canada regularly tweets about new medical devices approved.

The Medical Devices Active Licences Listing (MDALL) is a listing of all approvals (licences) issued for medical devices.

New Search for data about the tests and trials that were performed on medical devices to evaluate their safety and efficacy.

Regulatory Decision Summaries include the purpose of an application for a medical device licence and the reasons for Health Canada's decision to approve or reject it.

Summary Basis of Decision documents give the detailed regulatory, safety, effectiveness and quality considerations that factored into Health Canada's decision to approve certain medical devices.

Surveillance of medical devices

You can report medical device incidents 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.

The Recalls and Safety Alerts Database includes the recalls, advisories, safety alerts and other publications issued by Health Canada.

Summary Safety Reviews summarize our completed reviews of potential safety issues for medical devices.

New Safety and Effectiveness Reviews are tables listing reviews that are currently ongoing in Health Canada.

Health Product InfoWatch is a monthly publication intended primarily for healthcare professionals. The Health Product InfoWatch provides clinically relevant information about health products and their safety.

The summary tables of advertising complaints list the complaints about health product advertising that have been filed with Health Canada, and the action we have taken.

The Medical Devices Incident database includes suspected medical device incidents reported to Health Canada. These reports have been submitted by consumers and health professionals as well as medical device manufacturers.

Drugs for veterinary use

Drugs for veterinary use: 2019 in brief

Safe, effective and high quality drugs for veterinary use play an important role in protecting human and animal health. Health Canada evaluates and monitors the safety, quality and effectiveness of veterinary drugs. In doing so, we work to protect Canada's food supply.

This year one of our key priorities remained taking action to address antimicrobial resistance. We continued our work to improve the responsible use of antimicrobials in animals.

The world in which we work is changing rapidly and so are the drugs we regulate. We have focussed on developing flexible new regulatory tools. We have also continued our collaborations with our international partners. Together, these initiatives will help bring new drugs for veterinary use to the Canadian market.

The "Drugs for veterinary use: 2019 accomplishments" section describes our progress this year in this and other areas.

New health products approved

In 2019 we approved seven new drugs for companion and food-producing animals. This enabled access to innovative new products and therapies to help maintain and improve the health of animals.

We also approved seven new generic drugs to provide additional options for more cost-effective prevention and treatment.

For a list and description of the new drugs we approved in 2019, go to "Drugs for veterinary use: Approved in 2019".

This year we also helped make 723 veterinary health products available. These offer more low-risk options to maintain or promote health and wellness in animals.

Clinical trials and Emergency Drug Release Programme

We review applications to allow companies and researchers to conduct studies on veterinary drugs in Canada. New veterinary drug trials (called investigational drugs and experimental studies) mean Canadians may have access to new products in the future. In 2019, 87 Experimental Studies Certificates that support clinical trials or research activities were authorized.

Through our Emergency Drug Release Programme, we give access to drugs for veterinary use that are not available in Canada. We may grant access to veterinarians in the case of a medical emergency. In 2019, 671 requests under the Emergency Drug Release program were authorized.

Surveillance

After we approve a drug for sale in Canada, we continue to monitor and evaluate reports of suspected adverse veterinary drug reactions.

This "Drugs for Veterinary Use" chapter gives you more information about our work in 2019. For up-to-date information about our activities see the "Healthy clicks – Drugs for veterinary use at a glance" section, and follow us on social media.

Mary Jane Ireland,
Director General,
Veterinary Drugs,
Health Canada

Drugs for veterinary use: What's new in 2019

In 2019 Health Canada approved seven new drugs for veterinary use. More detail is available in the section "Drugs for veterinary use: Approved in 2019". 

New drugs for veterinary use

Drugs for veterinary use: 2019 accomplishments

Addressing antimicrobial resistance related to animals

Using antimicrobials in animals can affect the way that humans and animals respond to treatment.

Antimicrobials, such as antibiotics and antivirals, are used to treat people and animals. Bacteria, viruses, fungi and parasites can resist antimicrobials. This is known as antimicrobial resistance (AMR). The impact of AMR on human and animal health is a concern in Canada and around the world.

In animals, antimicrobial use contributes to the development and spread of resistant bacteria. These bacteria can be transferred to humans through direct contact with animals, and also through the animal products we eat.

Taking action to address antimicrobial resistance

A large portion of the antimicrobials sold in Canada are used in food-producing animals. In 2019 we continued to improve the oversight and responsible use of antimicrobials in animals.

Involving a licensed veterinarian in treatment decisions is an important part of overseeing antimicrobial use. Beginning in December 2018, many antimicrobials used in animals that were once available without a prescription ("over-the-counter") now require a prescription.

To help our stakeholders adapt to this change, we worked with our partners to develop a variety of tools such as prescription templates. For more information, go to Responsible use of medically important antimicrobials in animals.

In 2019 Health Canada launched the Veterinary Antimicrobial Sales Reporting System. This is an electronic tool that helps manufacturers, importers and compounders submit reports directly to Health Canada about the volume of certain antimicrobials they have sold. We will use this information to give us a better understanding of how antimicrobials are used in animals. It will also help us identify patterns of antimicrobial resistance. For more information, go to Veterinary antimicrobial sales reporting.

Our work to promote effective stewardship of veterinary antimicrobials is part of the Federal Action Plan on Antimicrobial Resistance and Use in Canada and the Pan-Canadian Framework for Action on Tackling Antimicrobial Resistance and Antimicrobial Use.

To learn about antimicrobial resistance related to humans, go to "Drugs for human use: 2019 accomplishments".

Focus on … AMR Awareness Week, November 18-22, 2019

Every year Health Canada, along with international health agencies, supports AMR Awareness Week. This global initiative aims to raise awareness of antimicrobial resistance and highlight best practices to help stop the spread of antibiotic resistance. To coincide with AMR Awareness Week, we launched a series of social media messages to raise awareness of this important issue as well as the joint statement on AMR that Health Canada issued with ICMRA.

Regulating innovative products

Scientific and technological advances have led to new ways to diagnose, treat and monitor animals. In 2019 Health Canada announced it would develop new regulations that are agile and that will support innovative new therapies.

As part of our ongoing Regulatory Innovation initiative, we are focusing on how we oversee clinical trials, approve complex new therapies and use foreign reviews and decisions.

Changing how we regulate experimental studies

Experimental studies are usually the first step in developing new veterinary drugs. As products evolve, so do experimental studies. We need regulations that are more flexible so that new veterinary drugs can be developed and tested. The level of oversight should be based on the potential risk of the study.

Health Canada will propose regulations that would streamline and clarify the processes for experimental studies for veterinary drugs. This approach will improve our alignment with regulators around the world. It will also encourage more sponsors to conduct studies in Canada.

Creating a flexible approach for approving complex new therapeutic products

Some therapeutic products are so novel, complex and distinct that they do not fit within our current regulations. We need a way to approve these products for veterinary use that is flexible and based on their potential risk.

Health Canada is proposing a new pathway for these "Advanced Therapeutic Products". Using this pathway, we will collaborate with stakeholders to create regulatory requirements that can be tailored to a specific product. It will allow us to manage these products throughout their life cycle, and still maintain our high standards for safety.

Improving access to products for minor uses and minor species

Health Canada is aiming to facilitate access to veterinary drugs for use in minor species (for example, farmed fish and sheep) and to treat rare and life-threatening conditions in major species (for example, cattle and chickens). Health Canada is exploring using foreign decisions to approve certain veterinary drugs that have been authorized by specified foreign regulators, have an adequate amount of post-market experience and meet internationally established food safety standards.

We know that it is important for Health Canada to be at the forefront of innovation. We will maintain, and invest in, our core business of reviewing drugs for veterinary use to protect the health and safety of Canadians and to protect Canada's food supply. Our discussions with stakeholders will continue as we develop our regulations, to make sure the regulations will respond to new science and technology and to the needs of Canadians.

Focus on … regulatory innovation

"This is a turning point for health product regulation as we work to ensure our regulations and programs adapt to the changing landscape of health product innovation. It is essential that the work we do protects the safety of Canadians and enables innovation to improve their health." - Elizabeth Toller, Executive Director, Regulatory Innovation, Health Canada

Providing more choices to improve animal health and wellness

By keeping animals healthy, we can reduce the need to use drugs, including antimicrobials. Veterinary health products are low-risk products that can help maintain or promote the health and wellness of animals. They include ingredients such as vitamins, minerals and traditional medicines.

More than 100 additional ingredients are now permitted in low-risk products. In 2019 we also helped make 723 veterinary health products available. Together, these will expand the range of choices available to animal owners and veterinarians. To learn more about products available, go to the List of Notified Products.

Collaborating internationally

Health Canada has a long history of working with regulators around the world. This co-operation ranges from ad-hoc meetings about global drug safety issues, to work with international organizations to harmonize our requirements for drugs.

We come together to combine our expertise, develop policies and set standards. Strong relationships with other countries:

Some examples of our collaborations with other international regulators in 2019 included:

For more information, go to Veterinary drugs – International collaboration.

Focus on … international collaboration

"Reviewing submissions under regulatory cooperation continues to strengthen our international relationships. Evaluators enjoy the opportunity to discuss submissions and challenges, finding that we often share the same concerns. Simultaneous reviews continue being a rewarding experience for all reviewers involved."

Dr. Elise Tatone,
Acting Senior Science Advisor,
Health Canada

Focus on … international collaboration

"Our collective work with Health Canada, Veterinary Drugs Directorate, has allowed us to build a collaborative environment where scientists from both countries are able to work together and share their respective expertise. The animal drug approvals that arise out of this partnership are incredibly beneficial to our public and animal health mission on a broader scale by increasing animal drug availability across our two countries. We look forward to continuing this work as we evaluate future animal drug applications."

Dr. Matthew Lucia,
Director,
Office of New Animal Drug Evaluation,
Center for Veterinary Medicine,
United States Food and Drug Administration

Focus on … product safety

In 2019 Health Canada implemented new software that allows veterinary drug manufacturers to report suspected adverse drug reactions electronically. This new system will enhance surveillance of veterinary drugs currently on the market to ensure their benefits continue to outweigh their risks.

Healthy clicks – Drugs for veterinary use at a glance

To stay informed about our activities:

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

New drugs approved

The Drug Product Database is a listing of all drugs approved for sale in Canada. In the database, many drugs are accompanied by their veterinary labelling, which describe the conditions of use of the product.

The Notice of Compliance database lists the approvals (Notices of Compliance or NOCs) issued for new drugs.

Surveillance of veterinary drugs

Report a veterinary drug adverse reaction.

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 Programme

Drugs that are not approved in Canada may be available through our Special Access Programme. In this program, access is given to an individual healthcare 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, effectiveness and quality data to assess the benefits and potential risks of the drugs. They also review the information that will be provided to healthcare 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 healthcare 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). An NOC 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 (RMPs) that are submitted by manufacturers as part of their drug submissions. An RMP 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 healthcare 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.

Drugs for human use: Approved in 2019

This section outlines the new drugs, generic drugs and biosimilars approved for sale in Canada in 2019, and the safety updates issued.

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.

Health categories

The drugs listed have been divided into categories according to the Anatomical Therapeutic Chemical Classification (ATC) System, a system of codes developed by the World Health Organization. ATC codes are often assigned according to the mechanism of action (that is, how the drug works) rather than the disease or condition to be treated.

We have included the indication of each new drug to give you some additional information. In addition, each new drug has a hyperlink to the Decision Summary (when available). These documents provide a brief overview of the rationale for our decision to approve the drug.

The categories are:

Important definitions

Aligned review

An aligned review is one where the drug company allowed information to be shared between Health Canada and heath technology assessment organizations.

Biologic drug

Biologic drugs are biologically-derived products such as vaccines, blood-derived products and products produced through biotechnology.

Biosimilar

A biosimilar is a biologic drug that enters the market subsequent to a previously authorized biologic drug in Canada with a demonstrated similarity to the previously authorized biologic drug.

Generic drug

A generic drug is a copy of a brand name product. Generic drugs contain the same medicinal ingredients as the brand name drug and are considered bioequivalent to the brand name drug. There may be many generic versions of one brand name drug. Generic drugs cost less, so approving generic drugs can mean considerable savings to the healthcare system.

New drug

New drugs give new and innovative options for treatment, prevention and diagnosis of various health conditions.

New active substance

A new drug that contains a medicinal ingredient not previously approved in a drug in Canada and that is not a variation of a previously approved medicinal ingredient.

Non-prescription ("over-the-counter") drug

Non-prescription drugs, also called over-the-counter (OTC) drugs, are products that can be bought without a doctor's prescription.

Notice of Compliance with conditions

A Notice of Compliance may be issued with Conditions (NOC/c) to a drug with promising clinical benefit, for a serious, life-threatening, or severely debilitating disease or condition. The manufacturer must still demonstrate that the product has an acceptable safety profile based on a benefit/risk assessment, 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 shorter review targets.

Orphan drug

Orphan drugs are used to treat rare diseases, and have received orphan designation in either the United States or the European Union.

Pediatric indication

This indicates that the drug has been approved for use in children less than 18 years old.

Priority review

Priority review status may be granted to a drug submission for a product for a serious, life-threatening, or severely debilitating disease or condition. Submissions that are granted priority review status are subject to shorter review targets.

Review with international partners

A review with international partners is one where Health Canada worked with certain regulators to share the work of drug reviews. For more information, go to "Drugs for human use: 2019 accomplishments".

Safety updates

Safety updates are designed to communicate information about potential health risks, so that patients and healthcare professionals can make informed decisions about their health.

For more information about the types of risk communications that can be found on the Government of Canada's website, go to "Healthy clicks – Drugs for human use at a glance".

Figure 1: New drugs, new generic drugs and new biosimilars approved in 2019

Figure 1: New drugs, new generic drugs and new biosimilars approved in 2019

Text description

Number of new drugs, generic drugs, and biosimilars approved in 2019, by ATC Category (the Anatomical Therapeutic Chemical Classification (ATC) System, a system of codes developed by the World Health Organization).

New drugs, new generic drugs and new biosimilars approved in 2019
ATC Category Number of new drugs approved Number of generic drugs approved Number of biosimilars approved
Alimentary tract and metabolism 2 10 0
Antiinfectives for systemic use 5 24 0
Antineoplastic and immunomodulating agents 21 27 5
Antiparasitic products, insecticides and repellents 0 2 0
Blood and blood forming organs 2 0 0
Cardiovascular system 3 14 0
Dermatologicals 1 3 0
Genito-urinary system and sex hormones 2 7 0
Musculo-skeletal system 1 7 0
Nervous system 5 22 0
Respiratory system 1 2 0
Sensory organs 3 4 0
Systemic hormonal preparations, excluding sex hormones and insulins 1 4 0
Various 6 3 0
Total new drugs approved in 2018 53 129 5

Alimentary tract and metabolism

For example, drugs for the gastrointestinal tract and drugs for diabetes.

2 New drugs were approved in this category

Jorveza
Trulance

10 New generic drugs were approved in this category

Safety updates published in this category

Antiinfectives for systemic use

For example, antibacterials, antivirals and vaccines.

5 New drugs were approved in this category

Dovato

Dovato Decision Summary

Flucelvax Quad

Flucelvax Quad Decision Summary

Influvac Tetra

Influvac Tetra Decision Summary

Ivozfo

Ivozfo Decision Summary

Xembify

Xembify Decision Summary

24 New generic drugs were approved in this category

Safety updates published in this category

Antineoplastic and immunomodulating agents

For example, drugs for the treatment of cancer and drugs that stimulate or suppress the immune system.

21 New drugs were approved in this category

Balversa
Calquence
Dacogen
Demylocan
Envarsus PA

Envarsus PA Decision Summary

Idhifa

Idhifa Decision Summary

Libtayo

Libtayo Decision Summary

Lorbrena

Lorbrena Decision Summary

Mylotarg

Mylotarg Decision Summary

Nerlynx
Rinvoq
Skyrizi

Skyrizi Decision Summary

Talzenna
Tolak
Ultomiris

Ultomiris Decision Summary

Verzenio
Vitrakvi
Vizimpro

Vizimpro Decision Summary

Xospata
Yescarta

Yescarta Decision Summary

Zejula

5 New biosimilars were approved in this category

Herzuma

Herzuma Decision Summary

Ogivri

Ogivri Decision Summary

Trazimera

Trazimera Decision Summary

Truxima

Truxima Decision Summary

Zirabev

Zirabev Decision Summary

27 New generic drugs were approved in this category

Safety updates published in this category

Antiparasitic products, insecticides and repellents

For example, drugs to treat infestations of parasites.

2 New generic drugs were approved in this category

Blood and blood forming organs

For example, drugs such as antihemorrhagics.

2 New drugs were approved in this category

Esperoct

Esperoct Decision Summary

Vonvendi

Vonvendi Decision Summary

Safety updates published in this category

Cardiovascular system

For example, drugs for high blood pressure and anticholesterol agents.

3 New drugs were approved in this category

pdp-amlodipine

pdp-amlodipine Decision Summary

Sandoz Bisoprolol Tablets
Vascepa

14 New generic drugs were approved in this category

Safety updates published in this category

Dermatologicals

For example, drugs for the skin such as drugs to treat acne.

1 New drug was approved in this category

Aklief

3 New generic drugs were approved in this category

Safety updates published in this category

Genito urinary system and sex hormones

For example, hormonal contraception, sex hormones and drugs for the urinary tract system.

2 New drugs were approved in this category

Intrarosa
Tibella

Tibella Decision Summary

7 New generic drugs were approved in this category

Safety updates published in this category

Musculo-skeletal system

For example, drugs affecting the muscles, bones and joints, including anti-inflammatories and muscle relaxants.

1 New drug was approved in this category

Evenity

Evenity Decision Summary

7 New generic drugs were approved in this category

Safety update published in this category

Nervous system

For example, drugs that affect the brain and the nervous system, including analgesics, antidepressants and anti-seizure medications.

5 New drugs were approved in this category

Combogesic
Emgality

Emgality Decision Summary

Onpattro

Onpattro Decision Summary

Onstryv

Onstryv Decision Summary

pdp-levetiracetam

22 New generic drugs were approved in this category

Safety updates published in this category

Respiratory system

For example, drugs that affect the respiratory system, including antihistamines.

1 New drug was approved in this category

Loratadine Soft Gelatin Capsules

2 New generic drugs were approved in this category

Safety update published in this category

Sensory organs

For example, drugs for the eyes.

3 New drugs were approved in this category

Cystadrops
Netildex (With Preservative), Netildex (Without Preservative)
Oxervate

Oxervate Decision Summary

4 New generic drugs were approved in this category

Systemic hormonal preparations, excluding sex hormones and insulins

For example, drugs that affect the endocrine system, including thyroid hormones.

1 New drug was approved in this category

Baqsimi

4 New generic drugs were approved in this category

Safety update published in this category

Various

For example, drugs unable to be classified into the other categories, such as diagnostic agents and drugs to treat high levels of potassium in the blood.

6 New drugs were approved in this category

Aridol

Aridol Decision Summary

Galli Eo

Galli Eo Decision Summary

Lokelma
Lutathera

Lutathera Decision Summary

Netspot

Netspot Decision Summary

SSP+

SSP+ Decision Summary

3 New generic drugs were approved in this category

Safety updates published in this category

Medical devices: Life cycle

As part of Health Canada's mission to help Canadians maintain and improve their health, we evaluate medical devices before and after they reach the Canadian market. Health Canada is involved throughout the life cycle of a medical device, from investigational testing to after the device is being sold in Canada.

Clinical trials (investigational testing)

Clinical trials are conducted by sponsors (manufacturers or importers) to gather information on a medical device's safety and effectiveness in humans. Sponsors of investigational tests submit their applications to conduct investigational testing with a medical device in Canada. Health Canada reviews these applications before the testing is conducted in Canada.

Special Access Programme

Medical devices that are not approved in Canada may be available through our Special Access Programme. In this program, access is given to an individual healthcare practitioner who is treating a specific patient. Access may be granted for emergency use, or when conventional therapies have failed, are unavailable or are unsuitable.

Medical device application and review

In Canada, medical devices are categorized in four groups based on their risk of use.  These groups are called "Classes" and range from I to IV. Class I devices are considered low-risk devices – for example, a wheelchair. Class IV devices present the greatest potential risk – for example, a defibrillator.

When a company decides that it would like to market a Class II, III or IV medical device in Canada, it files an application to Health Canada for a new medical device licence. The application contains scientific information about the medical device's safety, effectiveness and quality. Class I devices do not require a medical device licence, but are monitored through establishment licences.

Applications for higher-risk medical devices are reviewed by our scientists and engineers. Sometimes we also consult with advisory committees or external consultants. Reviewers evaluate the safety, effectiveness and quality data submitted to assess the potential benefits and risks of the medical devices. They also review the information that will be provided to healthcare practitioners and consumers about the medical device.

Expedited review pathway: Priority review

The priority review pathway provides an expedited path to a final decision for certain medical devices, including those that target specific healthcare needs. Medical devices for serious, life-threatening, or severely debilitating diseases or conditions can be given a priority review status. Products approved through expedited review pathways can be available to patients sooner because they have shorter review targets.

Approval of medical devices

After its review of a medical device application, Health Canada may conclude that the benefits of the product outweigh the potential risks and approve the device for sale in Canada. When a new medical device is approved, it is issued a medical device licence. This does not mean the medical device 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 problems related to a medical device 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. 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 medical device problems that are reported after products are approved for sale. These are undesirable effects potentially caused by medical devices.

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 medical device. 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 healthcare professionals of new safety information or recommending labelling changes. In the most serious situations, we may remove a medical device from the market.

Advertising complaints

Health Canada also regulates the advertising of medical devices 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.

Medical devices: Approved in 2019

There are different classes of medical devices, ranging from Class I to IV. Class I devices are considered low-risk devices, for example, a tongue depressor. Class IV devices present the greatest potential risk, for example, a pacemaker.

This section outlines the new Class IV medical devices approved for sale in Canada in 2019, and the safety updates issued.

You can report medical device incidents 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.

Health categories

The medical devices listed have been divided into categories according to the Global Medical Device Nomenclature (GMDN) system for naming and grouping medical devices.

We have included the indication of each new medical device to give you some additional information. In addition, each new device has a hyperlink to the Decision Summary (when available). These documents provide a brief overview of the rationale for our decision to approve the medical device.

The categories are

Important definitions

Medical device

Medical devices are products that are used for diagnostic and/or therapeutic purposes. Newly approved medical devices provide a broader range of products used to treat, manage, diagnose or prevent a disease or a physical condition.

Licence with conditions

A medical device licence may be issued with conditions set out by Health Canada. For example, the manufacturer may be required to submit additional information on an on-going basis for the medical device to demonstrate that it continues to meet our regulatory requirements.

Safety updates

Safety updates are designed to communicate information about potential health risks, so that patients and healthcare professionals can make informed decisions about their health.

For more information about the types of risk communications that can be found on the Government of Canada's website, go to "Healthy clicks – Medical devices at a glance".

Figure 2: New class IV medical devices approved in 2019

Figure 2: New class IV medical devices approved in 2019

Text description

Number of new Class IV medical devices approved in 2019, according to the Global Medical Device Nomenclature (GMDN) system for naming and grouping medical devices.

New class IV medical devices approved in 2019
Health Category Number of Class IV devices approved
Anaesthesia and respiratory devices 2
Body tissue manipulation and reparation devices 9
Cardiovascular devices 26
Dental devices 1
Disability-assistive products 1
In vitro diagnostic medical devices 12
Neurological devices 3
Plastic surgery and cosmetic devices 2
Total new Class IV medical devices approved in 2018 56

Anaesthesia and respiratory devices

For example, inhalation therapy devices.

2 New medical devices were approved in this category

FreeO2 Automated Oxygen Therapy Device

FreeO2 Automated Oxygen Therapy Device Decision Summary

Intellivent-ASV Software

Intellivent-ASV Software Decision Summary

Blood fluid and tissue management devices

For example, photopheresis systems.

Safety update published in this category

Body tissue manipulation and reparation devices

For example, bone matrix implants, sutures and robotic surgical systems.

9 New medical devices were approved in this category

da Vinci X Surgical System

da Vinci X Surgical System Decision Summary

DSM Biomedical Calcium Phosphate Cement

DSM Biomedical Calcium Phosphate Cement Decision Summary

DSM Biomedical Calcium Phosphate Cement With Microspheres

DSM Biomedical Calcium Phosphate Cement With Microspheres Decision Summary

Endoform Antimicrobial Dermal Template

Endoform Antimicrobial Dermal Template Decision Summary

Filasilk Sterilised Surgical Needled Suture

Filasilk Sterilised Surgical Needled Suture Decision Summary

Filasilk Sterilised Surgical Suture

Filasilk Sterilised Surgical Suture Decision Summary

Gentrix Surgical Matrix

Gentrix Surgical Matrix Decision Summary

Mericron XL Sterilised Surgical Needled Suture

Mericron XL Sterilised Surgical Needled Suture Decision Summary

Optium DBM Gel

Optium DBM Gel Decision Summary

Safety update published in this category

Cardiovascular devices

For example, cardiovascular catheters, vascular grafts and haemostatic agents.

26 New medical devices were approved in this category

Acticor

Acticor Decision Summary

Amplatzer Valvular Plug III

Amplatzer Valvular Plug III Decision Summary

Arctic Front Advance Pro

Arctic Front Advance Pro Decision Summary

Edwards Sapien 3 Ultra Transcatheter Heart Valve Systems

Edwards Sapien 3 Ultra Transcatheter Heart Valve Systems Decision Summary

Figulla Flex II PFO

Figulla Flex II PFO Decision Summary

Flow Re-Direction Endoluminal Device (Fred) System

Flow Re-Direction Endoluminal Device (Fred) System Decision Summary

Gore Molding & Occlusion Balloon Catheter

Gore Molding & Occlusion Balloon Catheter Decision Summary

Gore Viabahn VBX Balloon Expandable Endoprosthesis

Gore Viabahn VBX Balloon Expandable Endoprosthesis Decision Summary

Ilivia Neo 7 VR-T, VR-T DX, DR-T, HF-T, HF-T QP

Ilivia Neo 7 VR-T, VR-T DX, DR-T, HF-T, HF-T QP Decision Summary

Mitraclip G4 System

Mitraclip G4 System Decision Summary

Novasight Hybrid System

Novasight Hybrid System Decision Summary

Optowire III Pressure Guidewire

Optowire III Pressure Guidewire Decision Summary

Plexa and Plexa (ProMri) ICD Leads

Plexa and Plexa (ProMri) ICD Leads Decision Summary

Promus ELITE Monorail Everolimus-Eluting Platinum Chromium Coronary Stent System

Promus ELITE Monorail Everolimus-Eluting Platinum Chromium Coronary Stent System Decision Summary

PuraStat

PuraStat Decision Summary

Reprocessed ViewFlex Xtra Ice Catheter

Reprocessed ViewFlex Xtra Ice Catheter Decision Summary

Resolute Onyx Zotarolimus-Eluting Coronary Stent System

Resolute Onyx Zotarolimus-Eluting Coronary Stent System Decision Summary

RotaPro Rotational Atherectomy System
Soundbite Crossing System – Peripheral
Squid Liquid Embolic Agent

Squid Liquid Embolic Agent Decision Summary

Stellarex 0.035 inch OTW Drug-Coated Angioplasty Balloon

Stellarex 0.035 inch OTW Drug-Coated Angioplasty Balloon Decision Summary

True Dilatation Balloon Valvuloplasty Catheter

True Dilatation Balloon Valvuloplasty Catheter Decision Summary

Valiant Navion Thoracic Stent Graft System

Valiant Navion Thoracic Stent Graft System Decision Summary

Versacross RF Wire

Versacross RF Wire Decision Summary

Watchman FLX Left Atrial Appendage Closure Device with Delivery System

Watchman FLX Left Atrial Appendage Closure Device with Delivery System Decision Summary

Xience Sierra Everolimus Eluting Coronary Stent System

Xience Sierra Everolimus Eluting Coronary Stent System Decision Summary

Safety update published in this category

Dental devices

For example, dental bone matrix implants.

1 New medical device was approved in this category

Synthetic Mineral Collagen Composite Dental Bone Graft Matrix

Synthetic Mineral Collagen Composite Dental Bone Graft Matrix Decision Summary

Disability-assistive products

For example, hearing implant systems.

1 New medical device was approved in this category

MI1200 Synchrony Auditory Brainstem Implant

Gastro-urological devices

For example, intragastric balloons.

Safety update published in this category

General hospital devices

For example, infusion sets and insulin pumps.

Safety updates published in this category

In vitro diagnostic medical devices

For example, instrument/analyser and viral infection disease in vitro devices.

12 New medical devices were approved in this category

Alinity s System

Alinity s System Decision Summary

Alinity s Anti-HBc Assay (Donor Screening & Cadaveric Testing)

Alinity s Anti-HBc Assay (Donor Screening & Cadaveric Testing) Decision Summary

Alinity s Anti-HCV (Donor Screening & Cadaveric Testing)
Alinity s Chagas Assay (Donor Screening & Cadaveric Testing)
Alinity s HBsAg Assay (Donor Screening/Cadaveric)

Alinity s HBsAg Assay (Donor Screening/Cadaveric) Decision Summary

Alinity s HBsAg Confirmatory Reagent Kit

Alinity s HBsAg Confirmatory Reagent Kit Decision Summary

Alinity s HTLV I/II Assay (Donor Screening & Cadaveric Testing)
Beckman Coulter PK7400 Automated Microplate System

Beckman Coulter PK7400 Automated Microplate System Decision Summary

Elecsys Chagas (Donor Screening)
NEO Iris

NEO Iris Decision Summary

Procleix Zika Virus Assay (Donor Screening/Cadaveric Testing)

Procleix Zika Virus Assay (Donor Screening/Cadaveric Testing) Decision Summary

Virotrol Plus-R

Virotrol Plus-R Decision Summary

Neurological devices

For example, neurological monitors/monitoring systems and surgical procedure kits.

3 New medical devices were approved in this category

Codman CereLink ICP Monitoring System

Codman CereLink ICP Monitoring System Decision Summary

Neurology Pack

Neurology Pack Decision Summary

Spectra Wavewriter Spinal Cord Stimulator System

Obstetrical/gynaecological devices

For example, tampons and fetal monitors.

Safety updates published in this category

Plastic surgery and cosmetic devices

For example, tissue expanders.

2 New medical devices were approved in this category

CPX4 Breast Tissue Expander Smooth

CPX4 Breast Tissue Expander Smooth Decision Summary

Natrelle 133S Tissue Expander

Natrelle 133S Tissue Expander Decision Summary

Safety updates published in this category

Various

Applicable to medical devices generally.

Safety update published in this category

Drugs for veterinary use: Life cycle

Every year, we approve new veterinary drugs in Canada, giving more choices to help maintain and improve the health and well-being of animals. We work to protect human and animal health and the safety of Canada's food supply.

As part of our work to protect human and animal health and the safety of Canada's food supply, we evaluate veterinary drugs throughout the life cycle of a drug for veterinary use, from clinical trials to after the drug is being sold in Canada.

Clinical trials

Experimental studies certificates and investigational new drug applications support the development of potential new veterinary drugs or new uses of already approved products. Sponsors of clinical trials (including manufacturers and researchers) submit their applications to conduct a trial with a veterinary drug in Canada. Health Canada reviews these applications before the trial is conducted in Canada.

Emergency Drug Release Program

Drugs that are not approved in Canada may be available through our Emergency Drug Release program. This program gives access to veterinary drugs for the purpose of diagnosing or treating a medical emergency. Animals receiving drugs through this program must be under the care of a veterinarian.

Drug submission and review

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

Submissions for drugs are reviewed by our scientists to assess the potential benefits and risks to human and animal health. They also help to ensure veterinary drug labels have clear directions for use and warning statements.

Many veterinary drugs are intended for use in food-producing animals such as cattle, chickens and pigs. We work to ensure the safety of food that comes from animals treated with veterinary drugs. We do this by setting standards such as Maximum Residue Limits for veterinary drugs in foods, and establishing withdrawal periods.

Innovative reviews (international regulatory cooperation)

Through international regulatory cooperation, we conduct reviews of submissions for new and generic veterinary drugs with certain partners. These include the United States Food and Drug Administration Center for Veterinary Medicines, the Australian Pesticides and Veterinary Medicines Authority, and the New Zealand Ministry of Primary Industries.

These collaborative reviews bring veterinary drugs to market in Canada at the same time as in other countries, which would otherwise not be possible. As a result, companion animal owners, veterinarians and producers have faster access to safe, effective and quality veterinary drugs.

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 veterinary drug for sale in Canada. When a new veterinary 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 in Canada, as many other factors can influence that timeline.

Surveillance

After Health Canada approves a veterinary drug, we continue to monitor its use in the real world. We evaluate potential safety and effectiveness issues, and take action when there are identified problems.

Collecting information

Health Canada collects information about a product after it is approved from a variety of sources.

One source of information is suspected adverse events that are reported after products are approved for sale. Adverse events are unwanted or harmful events that occur after administration of a veterinary drug. Included are:

Evaluating safety signals

Health Canada evaluates adverse event reports submitted by manufacturers and the public (including animal owners and veterinarians), to find out if they are related to the administered drug(s). We work with manufacturers and veterinarians to ensure that any important safety information is communicated.

Drugs for veterinary use: Approved in 2019

You can report a veterinary drug reaction to Health Canada.

Important definitions

Generic drug

A generic drug is a copy of a brand name product. Generic drugs contain the same medicinal ingredients as the brand name drug and are considered bioequivalent to the brand name drug. There may be many generic versions of one brand name drug.

New drug

New drugs give new and innovative options for treatment, prevention and diagnosis of various health conditions.

New active substance

A new drug that contains a medicinal ingredient not previously approved in a drug in Canada and that is not a variation of a previously approved medicinal ingredient for veterinary use.

7 New drugs were approved for veterinary use

Adaxio Shampoo
Forceris
Galliprant
Simparica Trio
Synovex LA-F
Synovex LA-G
Vitrecto

7 New generic drugs were approved for veterinary use

Footnotes

Footnote 1

New biosimilar

Return to first footnote 1 referrer

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