2019 DRUG AND MEDICAL DEVICE HIGHLIGHTS - Helping you maintain and improve your health - Canada.ca
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DRUG AND MEDICAL DE VICE HIGHLIGHTS
Helping you maintain and improve your health
2019
DRUG AND MEDICAL DEVICE HIGHLIGHTS 2019 Helping you maintain and improve your health 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.
Health Canada is the federal department responsible for helping the people of Canada maintain and improve their health. Health Canada is committed to improving the lives of all of Canada’s people and to making this country’s population among the healthiest in the world as measured by longevity, lifestyle and effective use of the public health care system. Également disponible en français sous le titre : Préserver et améliorer votre santé : Faits saillants sur les médicaments et les instruments médicaux 2019 To obtain additional information, please contact: Health Canada Address Locator 0900C2 Ottawa, ON K1A 0K9 Tel.: 613-957-2991 Toll free: 1-866-225-0709 Fax: 613-941-5366 TTY: 1-800-465-7735 E-mail: publications@hc-sc.gc.ca © Her Majesty the Queen in Right of Canada, as represented by the Minister of Health, 2020 Publication date: May 2020 This publication may be reproduced for personal or internal use only without permission provided the source is fully acknowledged. Cat.: H161-11E-PDF ISSN: 2562-9816 Pub.: 190484
CONTENTS
WELCOME TO OUR 2019 HIGHLIGHTS REPORT...........................................................................................1
MESSAGE FROM THE CHIEF MEDICAL ADVISOR.........................................................................................2
MESSAGE FROM THE CHIEF REGULATORY OFFICER..................................................................................3
DRUGS FOR HUMAN USE................................................................................................................................5
2019 IN BRIEF.........................................................................................................................................5
WHAT’S NEW IN 2019.............................................................................................................................7
2019 ACCOMPLISHMENTS....................................................................................................................8
HEALTHY CLICKS – DRUGS FOR HUMAN USE AT A GLANCE............................................................18
MEDICAL DEVICES.........................................................................................................................................23
2019 IN BRIEF.......................................................................................................................................23
WHAT’S NEW IN 2019...........................................................................................................................25
2019 ACCOMPLISHMENTS..................................................................................................................26
HEALTHY CLICKS – MEDICAL DEVICES AT A GLANCE........................................................................32
DRUGS FOR VETERINARY USE.....................................................................................................................35
2019 IN BRIEF.......................................................................................................................................35
WHAT’S NEW IN 2019...........................................................................................................................36
2019 ACCOMPLISHMENTS..................................................................................................................37
HEALTHY CLICKS – DRUGS FOR VETERINARY USE AT A GLANCE....................................................42
DRUGS FOR HUMAN USE: LIFE CYCLE.......................................................................................................45
DRUGS FOR HUMAN USE: APPROVED IN 2019...........................................................................................47
MEDICAL DEVICES: LIFE CYCLE...................................................................................................................69
MEDICAL DEVICES: APPROVED IN 2019......................................................................................................71
DRUGS FOR VETERINARY USE: LIFE CYCLE...............................................................................................87
DRUGS FOR VETERINARY USE: APPROVED IN 2019..................................................................................89
DRUG AND MEDICAL DEVICE HIGHLIGHTS 2019
WELCOME TO OUR
2019 HIGHLIGHTS REPORT
Health Canada helps Canadians maintain and improve As with previous years, the Highlights report is divided
their health by providing timely access to safe and into three chapters: drugs for human use, medical
effective drugs and medical devices. devices and drugs for veterinary use. This year we
have added a “What’s New in 2019” section to each
In 2019 we welcomed our new Minister, the chapter, which highlights our key product approvals
Honourable Patty Hajdu, to the health portfolio. over the year.
The Prime Minister’s mandate letter to our Minister
outlines Health Canada’s key priorities to safeguard Throughout the report you will also find new “Focus
and improve the health and safety of Canadians. on…” features. These provide a closer look into our
scientific work and our international collaboration,
This year we focussed on two important dimensions and key examples of our work on product safety.
of our work, regulatory innovation and international
collaboration, to help give Canadians access to new This report provides an overview of our work in 2019.
and innovative products. We also continued to improve For the most up-to-date information on our activities,
transparency and reduce administrative burden, while see the “Healthy Clicks” sections. We also invite you to
maintaining our high standards of safety, efficacy follow @GovCanHealth on Twitter to learn about newly
and quality. approved drugs and medical devices.
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.
Pierre Sabourin Kendal Weber
Assistant Deputy Minister, Associate Assistant
Health Canada Deputy Minister,
Health Canada
1
DRUG AND MEDICAL DEVICE HIGHLIGHTS 2019
MESSAGE FROM THE
CHIEF MEDICAL ADVISOR
“The only thing that is constant is change”. This was as Some challenges to the health system, such as the
true when Heraclitus, the ancient Greek philosopher, opioid crisis, are being met with government-wide
uttered it as it is now. initiatives. In addition to our work on labelling and
warnings for opioids, over the past year we focussed
Science and technology continue to evolve, bringing on restricting the marketing and advertising of these
change to the way we live and the world around us. medications to ensure that they are used appropriately.
New therapies such as telehealth devices, 3D printing,
gene therapies and health products that use artificial Health Canada recognizes that the challenges we
intelligence are entering the global market at an face are not unique to our country. Our efforts such
advanced pace. These bring benefits to patients, but as the modernization of the way we oversee clinical
also challenges to regulatory organizations like Health trials and the creation of new pathways to assess novel
Canada. These smart technologies continue to inspire innovative therapies for Canadians are enriched by the
our transformation efforts to ensure that we are ready collaboration we have with international colleagues.
for the future. Health Canada has built strong relationships with
regulators worldwide to advance collaboration in our
This past year brought forth many innovative products work on new safety standards, and to lead efforts in
that will help Canadians maintain and improve their assessing new innovative products. Sharing work with
health. For example, Health Canada evaluated new other regulators maximizes our collective expertise and
medications that are unlike any other approved avoids duplication of effort. For example, collaboration
antibiotics, providing treatment options for hospitalized with Australia resulted in the approval of two new anti-
and critically ill patients with resistant infections. This cancer drugs in 2019.
past year also brought the approval of paradigm-
changing cancer treatments that are based on the The pace of change will
unique genetic makeup of an individual’s tumour, only get faster from here.
regardless of where in the body it first started. Enabling Our efforts to respond
the use of these treatments means that the health to innovation in this
system, including the role of the regulator, must evolve interconnected world will
as rapidly as the scientific advancements that give rise prepare us well for the road
to them. that lies ahead.
The health system is also evolving. For example,
in 2019 we approved several new pediatric
formulations for our youngest, and often most
Supriya Sharma
Chief Medical Advisor,
vulnerable, Canadians. These formulations mean that Health Canada
healthcare professionals no longer have to rely on the
longstanding practice of using medicines approved
for adults.
2
DRUG AND MEDICAL DEVICE HIGHLIGHTS 2019
MESSAGE FROM THE
CHIEF REGULATORY OFFICER
Canadian laws and regulations underpin the work We now release the clinical information that was
we do to protect the health and safety of Canadians. provided to us by companies, after we have made
Health Canada’s regulations enable us to: our final decision as to whether a drug or medical
approve clinical trials and approve requests device can be sold in Canada. This provides
through the Special Access Programme, Canadians access to clinical data on drugs and
medical devices to allow them to make well-
review and approve new drugs and medical
informed decisions about their health and that of
devices, and
their families. It will also encourage new research
monitor drugs and medical devices and take questions and make it easier for the clinical data to
appropriate action throughout their life cycle. be re-analysed independently, both of which could
ultimately result in new benefits for Canadians.
In 2019 we made improvements to the Food and Drugs
Act to make sure that Canadians can benefit from We updated our regulations for medical devices to
new research approaches and highly advanced types make them consistent with international standards.
of therapeutic products. We proposed an Advanced
We have also published regulations under the Assisted
Therapeutic Products pathway so that we can tailor
Human Reproduction Act that will support Canadians
our regulatory approach for certain products, such as
who use assisted human reproduction to safely build
those that rely on artificial intelligence, 3D bio-printing
their families. We strengthened safety standards
or types of cell technology. We also introduced more
and now offer the LGBTQ2+ community and single-
efficient and up-to-date ways to regulate clinical trials
intended parents more flexibility in building their families
and classify types of products.
through the directed donation process.
We implemented new regulations to increase our ability
In the coming months,
to monitor the safety of drugs and medical devices,
we will keep working on
and provide Canadians more information. Together,
modernizing health product
these regulations will help Canadians make well-
regulation for Canadians.
informed decisions about the health products they use.
We will continue our
Adverse reactions to drugs and medical device discussions with
incidents account for many emergency visits and stakeholders to ensure our
hospital admissions in Canada. Hospitals are now new regulations support
required to report serious adverse drug reactions innovation and protect
and medical device incidents. Health Canada Canadians. David K. Lee
will monitor these reports and provide healthcare Chief Regulatory Officer,
providers and patients with up-to-date information Health Canada
about the safety of their products.
3
DRUGS FOR HUMAN USE
4DRUGS FOR HUMAN USE
DRUGS FOR HUMAN USE
2019 IN BRIEF
Safe, effective and high quality drugs can help It is also important to bring more choice and more
Canadians maintain and improve their health. These affordable options to Canadians. We approved 129
include vaccines, as well as prescription and non- new generic drugs and 5 new biosimilars in 2019.
prescription (“over-the-counter”) medicines.
In 2019 Health Canada approved four new non-
Health Canada evaluates and monitors the benefits prescription (“over-the-counter”) drugs, offering
and risks of drugs throughout their life cycle, to make more options to Canadians for treating and
sure that the benefits outweigh the potential risks. This managing symptoms of minor ailments.
is the core of our work.
For a list and description of the new drugs we
However, the world in which we work is changing approved in 2019, go to “Drugs for Human Use:
rapidly and so are the drugs we regulate. We Approved in 2019”. In this section you will also
must keep pace with advances in science and learn how we addressed safety issues that arose for
technology. Two of our key priorities in 2019 focus drugs in Canada.
on these challenges:
Regulatory innovation: We are developing flexible
new regulatory tools that will help us bring novel CLINICAL TRIALS AND SPECIAL
treatments to Canadians. ACCESS PROGRAMME
International collaboration: We are working with We review applications to allow companies and
regulators around the world to help us share researchers to conduct clinical trials in Canada.
information and enhance our scientific knowledge. New clinical trials mean Canadians may have
access to more innovative treatment options. In
The “Drugs for Human Use: 2019 2019, 1089 new clinical trial applications for drugs
Accomplishments” section describes our progress were approved. Several involved complex, novel,
in these and other areas. adaptive clinical trial designs, and some trials will
facilitate participation of Canadians living in remote
areas.
NEW DRUGS APPROVED
In 2019 we approved 58 new drugs. These give Through our Special Access Programme, we give
patients more options for the treatment, prevention access to drugs that are not available in Canada.
and diagnosis of various health conditions. We may grant access to doctors for emergency use
or for the treatment of serious or life-threatening
Thirty-five of the new drugs we approved in 2019 conditions. In 2019, 12,314 requests for special
contained medicinal ingredients that have never access to drugs were authorized. This included
been approved for sale in Canada, what we call drugs for children and drugs for serious infections,
“new active substances”. Thirty-four percent as well as cancer treatments.
of these were approved through an expedited
pathway, including those that target specific
healthcare needs.
5DRUGS FOR HUMAN USE
SURVEILLANCE healthcare professionals of new safety information
or recommending labelling changes. In the most
After we approve a drug for sale in Canada,
serious situations, we may remove a drug from the
we continue to monitor and evaluate reports of
market.
suspected adverse reactions.
This “Drugs for Human Use” chapter gives you more
In 2019 we received 1,131,148 reports of adverse
information about our work in 2019. For up-to-date
reactions to drugs for human use. These come
information about our activities see the “Healthy
from domestic and international sources. We
Clicks – Drugs for Human Use At a Glance” section,
undertook 1,162 actions related to drugs. These
and follow us on social media.
actions can include informing the public and
John Patrick Stewart Celia Lourenco Manon Bombardier Marc Mes
Director General, Director General, Director General, Director General,
Therapeutic Products, Biologics and Genetic Non-Prescription Drugs, Marketed Health Products,
Health Canada Therapies, Health Canada Health Canada
Health Canada
6DRUGS FOR HUMAN USE
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 Antineoplastic and Musculo-Skeletal System
and Metabolism Immunomodulating Agents
(cont.) ▪ Evenity
▪ Jorveza
▪ Trulance ▪ Truxima* Nervous System
▪ Ultomiris
▪ Verzenio
Antiinfectives ▪ Combogesic
▪ Vitrakvi
for Systemic Use ▪ Emgality
▪ Vizimpro
▪ Onpattro
▪ Xospata
▪ Dovato ▪ Onstryv
▪ Yescarta
▪ Flucelvax Quad ▪ pdp-Levetiracetam
▪ Zejula
▪ Influvac Tetra ▪ Zirabev*
▪ Ivozfo Respiratory System
▪ Xembify
▪ Blood and Blood
Forming Organs ▪ Loratadine Soft Gelatin Capsules
Antineoplastic and
▪ Esperoct Sensory Organs
Immunomodulating Agents
▪ Vonvendi
▪ Cystadrops
▪ Balversa
Cardiovascular System ▪ Netildex
▪ Calquence
▪ Oxervate
▪ Dacogen
▪ Demylocan ▪ pdp-Amlodipine
▪ Envarsus PA ▪ Sandoz Bisoprolol Tablets Systemic Hormonal
▪ Herzuma* ▪ Vascepa Preparations, Excluding
▪ Idhifa Sex Hormones and Insulins
▪ Libtayo
Dermatologicals
▪ Lorbrena ▪ Baqsimi
▪ Mylotarg
▪ Nerlynx ▪ Aklief
▪ Ogivri* Various
▪ Rinvoq Genito Urinary System
▪ Skyrizi and Sex Hormones ▪ Aridol
▪ Talzenna ▪ Galli Eo
▪ Tolak ▪ Lokelma
▪ Intrarosa
▪ Trazimera* ▪ Lutathera
▪ Tibella
▪ Netspot
▪ SSP+
* New biosimilar
7DRUGS FOR HUMAN USE
DRUGS FOR
HUMAN USE:
2019 ACCOMPLISHMENTS
REGULATING
INNOVATIVE DRUGS
Scientific and technological advances have led to
new ways to diagnose, treat and monitor patients. Focus on…
For example, technologies like gene editing mean that OUR SCIENCE
products can be personalized to an individual patient.
In 2019 our regulatory scientists studying
In 2019 Health Canada announced it would develop biologic drugs published a paper titled
new regulations that are agile and that will support “Chitosan alters inactivated respiratory
innovative new therapies. Health Canada met with key syncytial virus vaccine elicited immune
stakeholders across the country and around the world responses without affecting lung
to better understand the changes we are seeing. We histopathology in mice”. Their work is
also discussed the challenges that stakeholders face focussed on the evaluation of a future vaccine
in bringing innovative new products to market. Health against the respiratory syncytial virus. This
Canada published a “What we heard” document that virus infects almost all children under the age
describes the key findings from these discussions. of one, and is a top priority of the World Health
Organization.
As part of our ongoing Regulatory Innovation initiative,
we are focussing on how we oversee clinical trials, Dr. Terry Cyr, Caroline Gravel,
approve complex new therapies and use foreign Research Scientist, Biologist, Health
Health Canada Canada
reviews and decisions.
Dr. Simon Sauvé, Marsha Russell,
Research Scientist, Biologist, Health
Changing how we regulate clinical trials Health Canada Canada
Clinical trials are usually the first step in developing Dr. Sean Li, Not pictured:
new drugs. As products evolve, so do clinical trials. Research Scientist, Abeneya
We need clinical trial regulations that are more Health Canada Muralidharan,
flexible so that new drugs can be developed and Louise Larocque, Graduate Student,
tested. The level of oversight should be based on Senior Research Health Canada
the potential risk of the trial. Technologist, Health Dr. Michael Rosu-
Canada Myles, Director, Health
Canada
8DRUGS FOR HUMAN USE
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 Focus on…
regulations. We need a way to approve these REGULATORY INNOVATION
products that is flexible and based on their
potential risk. “This is a turning point for health product
regulation as we work to ensure our regulations
Health Canada is proposing a new pathway for and programs adapt to the changing landscape
these “Advanced Therapeutic Products”. Using this of health product innovation. It is essential
pathway, we will collaborate with stakeholders to that the work we do protects the safety of
create regulatory requirements that can be tailored Canadians and enables innovation to improve
to a specific product. It will allow us to manage their health.”
these products throughout their life cycle, and still
maintain our high standards for patient safety. Elizabeth Toller
Executive Director, Regulatory Innovation,
Health Canada
Using foreign reviews and decisions
Health Canada has a process in place where we
may use information provided by other regulatory will continue as we develop our regulations, to make
agencies. We are now looking into ways we can sure the regulations will respond to new science and
build on this, to help increase access to drugs technology and to the needs of Canadians.
for Canadians. Health Canada is also exploring
opportunities to share work with our international
partners according to our respective expertise. BUILDING INTERNATIONAL
PARTNERSHIPS
We are also exploring using decisions of certain
Health Canada has a long history of working with
regulators to approve certain drugs that would meet
regulators around the world. This co-operation ranges
an unmet medical need. For example, this could
from ad-hoc meetings about global drug safety issues,
help bring some drugs that are currently accessed
to work with international organizations to harmonize
through the Special Access Programme to the
our requirements for drugs.
broader Canadian market.
We come together to combine our expertise, develop
We know that it is important for Health Canada to be policies and set standards. Strong relationships with
at the forefront of innovation. We will maintain, and other countries help us all address health risks more
invest in, our core business of reviewing innovative effectively. In addition, working together helps us all
and generic drugs to protect the health and safety of support timely access to safe new drugs.
Canadians. Our discussions with our stakeholders
9DRUGS FOR HUMAN USE
International Council for Harmonisation
(ICH) – The mission of ICH is to achieve greater
harmonisation worldwide to ensure that medicines
are developed and approved efficiently. Health
Canada is a member of ICH, and as such adopts
and implements all ICH guidelines and standards.
In 2019 Health Canada became Vice-Chair of
the ICH Assembly, and implemented three ICH
guidelines. For example, the “Good Clinical
Focus on… Practice” and “Multi Regional Clinical Trials”
INTERNATIONAL guidelines will help improve the quality and
efficiency of clinical trials for Canadians.
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
International Pharmaceutical Regulators
to us and we need to structure our relationship
Programme (IPRP) – The IPRP is a forum to
more.”
exchange information about pharmaceutical
Professor Guido Rasi products for human use, and enable regulatory
Executive Director, European Medicines Agency (EMA) cooperation. In 2019 Health Canada acted as
Vice-Chair of the IPRP Management Committee.
We also co-chaired two IPRP Working Groups:
Some examples of our collaborations with other Biosimilars and Nanomedicines.
regulators in 2019 included:
International Coalition of Medicines Regulatory Australia-Canada-Singapore-Switzerland
Authorities (ICMRA) – This organization focuses (ACSS) Consortium – Through the ACSS
on developing strategies to address issues that Consortium, Health Canada works with partners to
impact global health. It is led by the heads of the review new drugs together, to get them to market
agencies that regulate medicines from every region quickly and efficiently. In 2019 Health Canada
of the world. Health Canada is a founding member approved two products with Australia: Verzenio
of ICMRA, which involves 29 regulatory authorities. and Zejula. For more information, go to “Drugs for
In 2019, as part of ICMRA’s Innovation Project, Human Use: Approved in 2019”.
Health Canada led a group that examined new
ways to regulate innovation.
10DRUGS FOR HUMAN USE
Project Orbis – Project Orbis is an initiative of
the United States Food and Drug Administration
(FDA) Oncology Center of Excellence. Project
Orbis brings together regulators from multiple
countries to review cancer drugs at the same
time so that patients can receive earlier access
Focus on…
to needed treatments. Through the pilot project,
INTERNATIONAL
companies submit their information to all COLLABORATION
participating regulatory agencies at the same
“Project Orbis was a unique opportunity to
time and the agencies review the information
collaborate with our international partners that
collaboratively. This pilot can encourage earlier
enabled early access to a new treatment for
access to new drugs for Canadian patients. In
a disease with an unmet medical need. The
2019 Health Canada approved the use of Keytruda
aligned review allowed for real-time insights
in combination with Lenvima for endometrial
into the FDA review approach, analysis, and
carcinoma, and Calquence for adults with chronic
interpretation of data common to that submitted
lymphocytic leukemia through Project Orbis.
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
Canada-United States Regulatory Cooperation Dr. Jaigi Mathai,
Council (RCC) – The RCC was created to Senior Clinical Evaluator, Health Canada
reduce unnecessary differences between the Dr. Maxime Sasseville,
countries’ regulatory frameworks. As part of this Manager, Health Canada
work, Health Canada and the FDA continue to
hold joint consultation meetings on ICH guidance
documents. The results of these consultations PUBLISHING CLINICAL
inform discussions at subsequent ICH meetings. INFORMATION ABOUT DRUGS
They also help Health Canada better understand, FOR HUMAN USE
and work to minimize, areas where our
“Clinical information” is data about the safety and
requirements differ from those of the FDA.
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.
11DRUGS FOR HUMAN USE
Providing public access to this clinical information will
benefit Canadians by:
Focus on…
making it easier for the clinical data to be re- MEDICATION SAFETY WEEK,
analysed independently,
NOVEMBER 25-29, 2019
encouraging new research questions,
Every year during Medication Safety Week,
reducing the duplication of clinical trials, and
international regulators work together through
helping patients and healthcare providers make ICMRA to promote awareness about adverse
better decisions about their health. drug reactions. To coincide with Medication
Safety Week, Health Canada launched a series
We make clinical information available through our
of social media messages to help encourage
“Clinical Information Portal”. In 2019 we published
reporting of adverse drug reactions.
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
Focus on… Health Canada continues to look for ways to
strengthen our knowledge about the safety of drugs
INTERNATIONAL
on the Canadian market. Reports of adverse drug
COLLABORATION reactions (ADRs) help us identify emerging safety
TO IMPROVE DRUG SAFETY issues. However, we know that ADRs are under-
reported around the world. In addition, the reports that
In 2017 a Canadian case was reported of a
are submitted can be missing important information.
patient who had taken an anti-cancer drug and
then developed a tear in an artery wall. Health To help address these issues, in 2019 Health Canada
Canada reviewed the potential risks of these published final regulations that aim to increase the
types of products and found there may be a quantity and improve the quality of reports of serious
link between their use and structural changes ADRs. Hospitals are now required to report to Health
to the walls of arteries. The products are called Canada all serious ADRs, whether the ADR took place
“vascular endothelial growth factor receptor in the hospital or before a patient went to the hospital.
tyrosine kinase inhibitors (VEGFR TKIs)” and
they are approved in Canada for the treatment of To help hospitals implement this change, Health
various types of cancer. In 2019 Health Canada Canada helped to develop educational materials and
and the European Medicines Agency shared online tools to make it easier to submit reports.
information and reviews, and both regulators
put in place measures to help reduce the risk The additional, higher quality data will help Health
associated with the products. In Canada, we Canada improve the safety of drugs by:
are working with manufacturers to update the detecting new safety issues related to drugs,
product safety information for all VEGFR TKIs so assessing the impact of safety issues
that patients and healthcare professionals are for Canadians,
informed of the risk.
updating the drug labelling, and
publishing warnings or issuing recalls
when needed.
12DRUGS FOR HUMAN USE
USING REAL WORLD EVIDENCE
During drug development, sponsors (researchers and Focus on…
manufacturers) conduct clinical trials to demonstrate
DRUG SAFETY
that a drug is safe and effective. However, it may
be challenging to conduct clinical trials for certain In the summer of 2018, potentially unsafe
diseases (such as rare diseases) or patient populations levels of an impurity were identified in some
(such as children or pregnant women). In these cases, lots of drugs containing valsartan. These
information about how drugs are being used after impurities could be cancer causing. This
they are available for sale can help us understand how prompted an investigation that resulted in a
to use the drugs safely and effectively. We call this recall of affected valsartan products. In 2019
information “real world evidence”. Health Canada continued to work closely
with regulators worldwide to understand and
The use of real world evidence already informs our
address this issue. Similar impurities were
decisions throughout the life cycle of a drug. It is used
found in other drugs in the “sartan” class,
in the review of new drugs, and to monitor the safety
and later in drugs containing ranitidine. We
and effectiveness of drugs once they are available for
continued to investigate the root causes and
sale in Canada. The availability of real world evidence
we set strict limits for the impurity. Other areas
is increasing steadily worldwide. Health Canada
of Health Canada inspected manufacturing
is working with key partners to make sure that the
sites, and tested drug products in laboratories.
evidence we collect can help assess the safety and
We sent letters to manufacturers to inform
effectiveness of a drug throughout its life cycle.
them about the factors that can cause these
Health Canada will continue to use high quality real impurities to form, and steps they should take
world evidence to support our decisions, to help to make sure the impurities are not present in
protect the health and safety of Canadians and to their products.
increase patient access to treatments.
13DRUGS FOR HUMAN USE
ADDRESSING THE OPIOID CRISIS This past year, we took additional steps to further
restrict the marketing and advertising of
The opioid crisis continues to be one of the most
prescription opioids. All promotional materials must
serious public health issues in Canada’s recent history.
be limited to only statements that have been approved
Increasing access to treatments, as well as harm
by Health Canada in the Product Monograph.
reduction options, is a key element in addressing the
Statements have to be presented verbatim, and
opioid crisis.
convey the benefits and risks of opioids in a balanced
In 2019 Health Canada became the first country in way. These measures build on already-announced
the world to approve injectable hydromorphone in initiatives to address the pharmaceutical industry’s
adults with severe opioid use disorder. We also added opioid marketing and advertising practices.
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. REGULATORY REVIEW OF
This list enables medical officers of health to import DRUGS AND DEVICES
drugs that are not yet available in Canada but have Health Canada developed the “Regulatory Review
been approved for sale in certain other countries, to of Drugs and Devices” initiative in 2017 to provide
meet an urgent public health need. Diacetylmorphine patients with more timely access to drugs and medical
can now be imported for the treatment of opioid devices. Other goals include increasing our work with
use disorder. 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.
14DRUGS FOR HUMAN USE
ADDRESSING ANTIMICROBIAL
Focus on… RESISTANCE
AMR AWARENESS WEEK, Antimicrobials, such as antibiotics and antivirals, are
used to treat people and animals. Bacteria, viruses,
NOVEMBER 18-22, 2019
fungi and parasites can resist antimicrobials. This is
Every year Health Canada, along with known as antimicrobial resistance (AMR). The misuse
international health agencies, supports AMR and over-use of antimicrobials has led to the rapid
Awareness Week. This global initiative aims development and spread of AMR in Canada and
to raise awareness of antimicrobial resistance around the world.
and highlight best practices to help stop the
Antimicrobials are essential in modern health care.
spread of antibiotic resistance. To coincide
When they do not work as well as they should, we are
with AMR Awareness Week, we launched
less effective at treating common infectious diseases.
a series of social media messages to raise
This is a major threat to global public health, economic
awareness of this important issue as well
prosperity and security.
as the joint statement on AMR that Health
Canada issued with ICMRA. 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
In 2019 Health Canada continued to achieve significant
review, because it targeted difficult-to-treat pathogens
progress in support of drug access. For example, we
on our Pathogens of Interest List.
continued to align our review processes with those
of the health technology assessment organizations As part of our work with international partners, Health
(Canadian Agency for Drugs and Technologies in Canada led the development of a joint statement on
Health [CADTH], and Institut national d’excellence en AMR from ICMRA. We also issued a challenge under
santé et services sociaux [INESSS]). This alignment Innovative Solutions Canada. This challenge will fund
helps drugs reach patients more quickly. We approved the development of a novel tool so that health care
14 new drugs with this “aligned review” process in providers can detect or diagnose antibiotic resistant
2019. For more information, go to “Drugs for Human bacteria in humans or animals.
Use: Approved in 2019”.
To learn about antimicrobial resistance related to
We also launched a pilot project to provide early animals and veterinary drugs, go to “Drugs for
parallel scientific advice to companies with CADTH. Veterinary Use: 2019 Accomplishments”.
This project will help companies understand the
requirements of both Health Canada and its health
technology assessment partners, at the same time. PROVIDING MORE COST-
This work will help companies create more effective EFFECTIVE TREATMENT
drug development plans.
OPTIONS
We consulted on a draft guidance document on Generic and biosimilar drugs provide additional options
accelerated reviews to meet healthcare system needs. for more cost-effective prevention and treatment.
This approach will help improve access to those drugs
Generic drugs contain the same medicinal ingredients
that are needed most by Canadians.
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
15DRUGS FOR HUMAN USE
Australia-Canada-Singapore-Switzerland (ACSS) to other product-specific identifiers such as the Drug
Consortium Generic Medicines Work Sharing Trial. Identification Number (DIN). This naming convention
In this program, a submission for a generic drug is filed supports product-specific identification of biologic
with multiple countries in the ACSS Consortium and drugs, including biosimilars, throughout the medication
the review work is shared between countries. use process and in adverse drug reaction reporting.
Biosimilars are biologic drugs that enter the market Health Canada also updated our Biosimilar biologic
subsequent to a previously authorized drug in Canada drugs in Canada: Fact Sheet to provide additional
with a demonstrated similarity to the previously information to health professionals and patients
authorized biologic drug. about biosimilars and their regulation in Canada. In
addition, we contributed to the International
In 2019 Health Canada provided a number of Coalition of Medicines Regulatory Authorities
publications to support biosimilars regulation and (ICMRA) statements on biosimilars for healthcare
stakeholder education. We published a Policy professionals and patients and the general public.
Statement on the Naming of Biologic Drugs. Under These statements give assurance that regulators have
this policy, biologic drugs including biosimilars can be robust processes in place for the authorization and
clearly identified by use of the unique brand name and monitoring of biosimilars.
non-proprietary (medicinal ingredient) name, in addition
NON-PRESCRIPTION DRUGS
Health Canada is responsible for the review of non-
prescription drugs, also known as “over-the-counter”
products, to ensure that they are safe, effective and
of high quality. These products include, but are not
limited to:
antiseptics,
pain relievers,
cold and cough medicines, and
sunscreens.
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
Focus on… the product. Health Canada issues a Drug Identification
SAFETY Number (DIN) to every approved non-prescription
drug. Canadians should look for this number on the
“It’s very important that people use non- product label, which indicates that the drug has met
prescription drugs appropriately. Through our requirements.
the introduction of the Canadian Drug
Facts Table, we hope to promote the safe In 2019 Health Canada approved four new non-
use of medications and reduce preventable prescription drugs, offering more options to Canadians
medication errors.” for treating and managing symptoms of minor ailments.
Jason DiMuzio
Label Review Coordinator, Health Canada
16DRUGS FOR HUMAN USE
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.
Focus on…
In recent years, Health Canada introduced new OUR SCIENCE
requirements for labels so that information about non-
In 2019 our regulatory scientists studying
prescription drugs is easier to read, understand and
biologic drugs published a paper titled
locate on the package. Our requirements include larger
“Remarkable Structural Diversity of N-Glycan
text size, better contrast and a greater emphasis on
Sulfation on Influenza Vaccines”. The
providing Canadians with the information they need.
publication describes their analysis of the sugar-
In addition, for a consistent look and feel, structure of the influenza vaccine. Their work
important information about a non-prescription will contribute to a better understanding of the
drug is presented in a tabular format called the influenza vaccine.
Canadian Drug Facts Table.
Dr. Sean Li, Research Scientist, Health Canada
In 2019 Health Canada approved 516 non-prescription Dr. Terry Cyr, Research Scientist, Health Canada
drug submissions that met our new requirements. Yi-Min She, Research Chemist, Health Canada
We expect that non-prescription drugs with these
new labels will be available soon.
17DRUG AND MEDICAL DEVICE HIGHLIGHTS 2019 HEALTHY CLICKS –
DRUGS FOR HUMAN
USE AT A GLANCE
HEALTHY CLICKS
DRUGS FOR HUMAN USE AT A GLANCE
To stay informed about our activities:
Follow us on Facebook Follow us on Twitter Follow us on YouTube
facebook.com/HealthyCdns twitter.com/GovCanHealth youtube.com/user/HealthyCdns
See the latest news from Find other Health-related information on the
Health Canada on our website Government of Canada website
canada.ca/en/health-canada.html canada.ca/en/services/health.html
You can also find specific information about drugs by following the links below.
NEW DRUGS APPROVED
Health Canada regularly tweets
about new drugs approved.
Twitter #Drugandmeddevice
twitter.com/GovCanHealth
The Drug and Health Product Register provides The Drug Product Database is a listing of
information for consumers about drugs that are all drugs approved for sale in Canada. In the
currently marketed in Canada. database, many drugs are accompanied by
their Product Monographs, which describe the
Drug and Health Product Register conditions of use of the product.
hpr-rps.hres.ca/index.php
Drug Product Database
health-products.canada.ca/dpd-bdpp/
18DRUGS FOR HUMAN USE
NEW DRUGS APPROVED (cont.)
Search for data about the tests and trials that Clinical information on drugs NEW
were performed on drugs to evaluate their safety and health products
and efficacy. canada.ca/en/health-canada/services/drug-
health-product-review-approval/clinical-information-
drugs-health-products.html
The Submissions Under Review Lists show The Generic Submissions Under Review List
the drugs that are currently being reviewed by shows the generic drugs that are currently being
Health Canada. reviewed by Health Canada.
Submissions Under Review Lists Generic Submissions Under Review List
canada.ca/en/health-canada/services/drug-health- canada.ca/en/health-canada/services/drug-health-
product-review-approval/submissions-under-review.html product-review-approval/generic-submissions-under-
review.html
The Notice of Compliance database lists the
approvals (Notices of Compliance or NOCs) issued Summary Basis of Decision documents give
for new drugs. the detailed regulatory, safety, effectiveness and
quality considerations that factored into Health
Notice of Compliance database Canada’s decision to approve certain drug
health-products.canada.ca/noc-ac/index-eng.jsp submissions.
Regulatory Decision Summaries include the Summary Basis of Decision
purpose of a drug submission and the reasons for https://health-products.canada.ca/noc-ac/
Health Canada’s decision to approve or reject it. index-eng.jsp
Regulatory Decision Summary
canada.ca/en/health-canada/services/drugs-health-
products/drug-products/regulatory-decision-summary.
html
DRUG SHORTAGES
The Drug Shortages in Canada website gives Drug Shortages in Canada
information on actual and anticipated canada.ca/en/health-canada/services/drugs-health-
products/drug-products/drug-shortages.html
drug shortages.
CLINICAL TRIALS FOR DRUGS
The Clinical Trials Database lists the clinical Health Canada’s Clinical Trials Database
trial applications that have been approved for canada.ca/en/health-canada/services/drugs-health-
products/drug-products/health-canada-clinical-trials-
drugs in Canada. database.html
19DRUGS FOR HUMAN USE
SURVEILLANCE OF DRUGS
REPORT AN ADVERSE DRUG REACTION
Canada Vigilance Program
canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/adverse-reaction-reporting.html
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 Summary Safety Reviews summarize our
includes the recalls, advisories, safety alerts and completed reviews of potential safety issues
other publications issued by Health Canada. for drugs.
Recalls and Safety Alerts Database Summary Safety Reviews
healthycanadians.gc.ca/recall-alert-rappel-avis hpr-rps.hres.ca/reg-content/summary-safety-review.php
New Safety and Effectiveness Reviews are Health Product InfoWatch is a monthly
tables listing reviews that are currently ongoing in publication intended primarily for healthcare
Health Canada. professionals. The Health Product InfoWatch
provides clinically relevant information about health
New Safety Reviews products and their safety.
canada.ca/en/health-canada/services/drugs-health-
products/medeffect-canada/safety-reviews/new.html
Health Product InfoWatch
canada.ca/en/health-canada/services/
The Canada Vigilance Adverse Reaction Online drugs-health-products/medeffect-canada/
Database includes information about suspected health-product-infowatch.html
adverse reactions to health products and about
medical device incidents. These reports have been The summary tables of advertising complaints
submitted by consumers and health professionals list the complaints about health product
as well as drug manufacturers and distributors. advertising that have been filed with Health
Canada, and the action we have taken.
Canada Vigilance Adverse
Reaction Online Database Health Product Advertising Complaints
canada.ca/en/health-canada/services/drugs-health- hpr-rps.hres.ca/reg-content/summary-safety-review.php
products/medeffect-canada/adverse-reaction-database.
html
20DRUGS FOR HUMAN USE
21MEDICAL DEVICES
22MEDICAL DEVICES
MEDICAL DEVICES
2019 IN BRIEF
Safe, effective and high quality medical devices can The “Medical Devices: 2019 Accomplishments”
help Canadians maintain and improve their health. section describes our progress this year in these and
Medical devices are used in the treatment, diagnosis other areas.
or prevention of diseases or abnormal physical
conditions. Making safe and effective medical devices available to
Canadians in a timely manner is the core of our work.
In Canada, medical devices are categorized into four In the “Medical Devices: Approved in 2019” section
groups based on the level of risk associated with their you will learn about the new high-risk medical devices
use. These groups are called “Classes” and range from we approved, and how we addressed safety issues
I to IV. Class I devices are considered low-risk devices that arose.
– for example, a wheelchair. Class IV devices present
the greatest potential risk – for example, a defibrillator.
NEW MEDICAL DEVICES
Health Canada provides timely access to new and APPROVED
innovative technology, while overseeing the safety
In 2019 we approved 360 new medical devices
and effectiveness of the medical devices on the
in the highest risk categories (Classes III and IV).
Canadian market.
These devices provide patients and healthcare
The Medical Devices Action Plan continued to be professionals with new and innovative options for
one of our key priorities this year. The objective of the the treatment, prevention and diagnosis of various
Action Plan is to strengthen the regulation of medical health conditions.
devices in Canada by:
For a list and description of the 56 new Class IV
improving how devices get on the market, (highest-risk) medical devices we approved in 2019,
strengthening, monitoring and follow-up of devices go to “Medical Devices: Approved in 2019”.
once they are being used by Canadians, and
providing more information to Canadians about the
medical devices they use. INVESTIGATIONAL TESTING AND
SPECIAL ACCESS PROGRAMME
In 2019 we made significant progress in meeting
We review applications to allow companies to
these goals. We expanded our scientific expertise,
conduct investigational testing on medical devices
strengthened our monitoring of medical devices and
in Canada. New trials mean Canadians may have
provided more information to Canadians about the
access to more innovative choices. In 2019, 144
medical devices they use.
new investigational testing applications for medical
For example, we created a Scientific Advisory devices were approved.
Committee on Health Products for Women. This
Through our Special Access Programme, we give
committee gives voice to patient advocates, physicians
access to medical devices that have not been
and researchers on current and emerging issues
approved for sale in Canada. We grant access to
relating to women’s health, and the regulation of the
doctors for emergency use or when alternatives are
medical devices and drugs that they use.
unsuitable or unavailable. In 2019, 2829 requests for
special access to medical devices were authorized.
23MEDICAL DEVICES
SURVEILLANCE This “Medical Devices” chapter gives you more
information about our work in 2019. For up-to-date
After we approve a medical device for sale in
information about our activities see the “Healthy
Canada, we continue to monitor and evaluate
Clicks – Medical Devices At a Glance” section, and
reports of suspected incidents involving that
follow us on social media.
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.
John Patrick Stewart Marc Mes
Director General, Director General,
Therapeutic Products, Marketed Health Products,
Health Canada Health Canada
24MEDICAL DEVICES
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 Cardiovascular Devices (cont.) In Vitro Diagnostic Medical
Respiratory Devices Devices
▪ Ilivia Neo 7 VR-T, VR-T DX,
▪ FreeO2 Automated Oxygen DR-T, HF-T, HF-T QP ▪ Alinity S System
Therapy Device ▪ MitraClip G4 System ▪ Alinity S Anti-HBc Assay (Donor
▪ Intellivent-ASV Software ▪ Novasight Hybrid System Screening & Cadaveric Testing)
▪ Optowire III Pressure Guidewire ▪ Alinity S Anti-HCV (Donor
▪ Plexa and Plexa (ProMRI) ICD Leads Screening & Cadaveric Testing)
Body Tissue Manipulation and ▪ Promus ELITE Monorail Everoliums- ▪ Alinity S Chagas Assay (Donor
Reparation Devices Eluting Platinum Chromium Screening & Cadaveric Testing)
Coronary Stent System ▪ Alinity S HBsAg Assay (Donor
▪ da Vinci X Surgical System ▪ PuraStat Screening/Cadaveric)
▪ DSM Biomedical Calcium ▪ Reprocessed ViewFlex ▪ Alinity S HBsAg Confirmatory
Phosphate Cement Xtra ICE Catheter Reagent Kit
▪ DSM Biomedical Calcium ▪ Resolute Onyx Zotarolimus- ▪ Alinity S HTLV I/II Assay (Donor
Phosphate Cement with Eluting Coronary Stent System Screening & Cadaveric Testing)
Microspheres ▪ RotaPro Rotational ▪ Beckman Coulter PK7400
▪ Endoform Antimicrobial Atherectomy System Automated Microplate System
Dermal Template ▪ SoundBite Crossing System ▪ Elecys Chagas (Donor Screening)
▪ Filasilk Sterilised Surgical ▪ Squid Liquid Embolic Agent ▪ NEO Iris
Needled Suture ▪ Stellarex 0.035 inch OTW Drug- ▪ Procleix Zika Virus Assay (Donor
▪ Filasilk Sterilised Surgical Suture Coated Angioplasty Balloon Screening/Cadaveric Testing)
▪ Gentrix Surgical Matrix ▪ True Dilatation Balloon ▪ Virotrol Plus-R
▪ Mericron XL Sterilised Valvuloplasty Catheter
Surgical Needled Suture ▪ Valiant Navion Thoracic
▪ Optium DBM Gel Stent Graft System Neurological Devices
▪ VersaCross RF Wire
▪ Watchman FLX Left Atrial ▪ Codman Cerelink ICP
Cardiovascular Devices Appendage Closure Monitoring System
▪ Xience Sierra Everolimus Eluting ▪ Neurology Pack
▪ Acticor Coronary Stent System
▪ Spectra Wavewriter Spinal
▪ Amplatzer Valvular Plug III Cord Stimulator System
▪ Arctic Front Advance Pro
▪ Edwards Sapien 3 Ultra
Dental Devices
Transcatheter Heart Valve Systems Plastic Surgery and Cosmetic
▪ Figulla Flex II PFO ▪ Synthetic Mineral Collagen Devices
▪ Flow Re-Direction Endoluminal Composite Dental Bone Graft Matrix
Device (FRED) System ▪ CPX4 Breast Tissue
▪ Gore Molding & Occlusion Disability-assistive Products Expander Smooth
Balloon Catheter ▪ Natrelle 133S Tissue Expander
▪ Gore Viabahn VBX Balloon
Expandable Endoprosthesis ▪ MI1200 Synchrony Auditory
Brainstem Implant
25MEDICAL DEVICES
MEDICAL DEVICES
2019 ACCOMPLISHMENTS
REGULATING These changes will improve the safety of
INNOVATIVE DEVICES participants in trials and align our approach with
other regulators. It will also encourage research
Scientific and technological advances have led to
in Canada.
new ways to diagnose, treat and monitor patients.
For example, technologies like 3D printing and artificial
intelligence mean that products can be personalized Creating a flexible approach for
to an individual patient. approving complex new medical devices
Some therapeutic products are so novel, complex
In 2019 Health Canada announced it would develop
and distinct that they do not fit within our current
new regulations that are agile and that will support
regulations. We need a way to approve these
innovative new therapies. Health Canada met with key
types of products that is flexible and based on
stakeholders across the country and around the world
their potential risk.
to better understand the changes we are seeing. We
also discussed the challenges that medical device Health Canada is proposing a new pathway for
manufacturers and other stakeholders face in bringing these “Advanced Therapeutic Products”. Using this
innovative new products to market. Health Canada pathway, we will collaborate with stakeholders to
published a “What we heard” document that create regulatory requirements that can be tailored
describes the key findings from these discussions. to the specific product. It will allow us to manage
these products throughout their life cycle, and still
As part of our ongoing Regulatory Innovation Initiative,
maintain our high standards for patient safety.
we are focussing on how we oversee investigational
testing and approve complex new therapies.
We know that it is important for Health Canada to be
at the forefront of innovation. We will maintain, and
Changing how we regulate invest in, our core business of reviewing innovative
investigational testing new medical devices to protect the health and safety
Investigational testing is usually the first step in of Canadians. Our discussions with stakeholders
developing new medical devices. Health Canada will continue as we develop our regulations, to make
is enhancing patient protection by strengthening sure the regulations will respond to new science and
the way clinical trials involving medical devices are technology and to the needs of Canadians.
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.
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