Pharmacovigilance in Canada
How is it with the drug safety system in the “Great White North”? Read our guide to get a clear picture.
And of course, if you feel you need a local consultant, we’re here for you.
Current status of our Canadian pharmacovigilance services:
QPPV in Canada
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Local Literature Screening
AVAILABLE
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Who is the main PV authority in Canada?
RESPONSIBILITY FOR NATIONAL PV SYSTEM
The main authority on pharmacovigilance in Canada is Health Canada, which oversees the safety and effectiveness of health products through its Marketed Health Products Directorate (MHPD).
The PV system in Canada does not have any regional centres. Health Canada is headquartered in Ottawa and the agency itself operates under the Department of Health.
Interesting website sections related to pharmacovigilance
DRUG PRODUCTS
Literally everything you need to know about drugs in Canada can be found in this section, wheter you’re looking for Applications and Submissions (inluding guidance on it), Drug shortages or Fact sheets, it’s all there. All these subsection can be found on the left side on the linked page.
DRUG PRODUCT DATABASE (DPD)
To find out which drugs are approved for sale in Canada, availability of drugs in Canada or product monographs for human medications use DPD. There is also nice guide how to se the databse.
MEDEFFECT e-NOTICE
Notifications on health product alerts directly to your email, with important information about advisories and recalls, which will keep you informed about the safety and effectiveness of health products after they hit the market.
RECORDS & SAFETY ALERTS
Vast library containing recalls, advisories and safety alerts. When searching for something concrete there, we recommend to use advanced search, using thath you can filter the theme areas that you’re interested in.
LEGISLATION
All importance laws and restrictions at glance, you’ll probably be most interested in the legislation regarding drug products, which has some subsections, such as acts themselves, gudiance etc.
DRUG & HEALTH PRODUCT PORTAL
Classical database with general infromation about drug products, just the search by the name, it’s really easy. Also if you’re not sure how to spell the name, don’t worry, the search system will help you.
VIGILANCE ADVERSE REACTION DATABASE
User-friendly online database. It does not contain data as of today, it is missing about the last half year. When you enter the website, you’ll clearly see step by step what to do to get your search result.
Other important institutions & industry groups
HEALTH PORTFOLIO
The Minister of Health oversees the federal government’s Health Portfolio, which includes several key agencies such as Health Canada and the Public Health Agency of Canada, which are responsible for various aspects of public health and healthcare policy in the country.
Health portofilo does not have its own website as such, probably because it is itself made up of several other agencies (Canadian Food Inspection Agency, Canadian Institutes of Health Research, Health Canada, Patented Medicine Prices Review Board, Public Health Agency of Canada). For each of these agencies you’ll find there a link that will redirect you to their websites, it still stands that the main information website on pharmacovigilance is Health Canada.
Ministry’s website: https://www.canada.ca/en/health-canada/corporate/health-portfolio.html
CANADIAN INSTITUTES OF HEALTH RESEARCH (CIHR)
CIHR is the federal funding agency for health research in Canada. It supports research initiatives aimed at improving health outcomes and strengthening the health care system. The agency comprises 13 institutes that focus on various health-related research areas.
You can read more about how the COVID-19 pandemic has highlighted the weaknesses in Canadian health systems and the urgent need for systemic change. Health research can be sometimes viewed as something very distant from ordinery life, though it plays a vital role in our everyday lives by helping to prevent diseases and injuries. If you want get more close to it, visit this section sharing inspiring stories of CIHR-funded research that is improving our lives. Also if you’d like more numbers and want to get to know CIHR activities better, head to this section for a breakdown of CIHR’s investments.
CIHR’s website: https://cihr-irsc.gc.ca/e/193.html
BIOTECanada
BIOTECanada is a national industry association representing the Canadian biotechnology industry. It focuses on promoting the growth and development of biotechnology enterprises in Canada.
On their website you can find nice overview of the biotech indsutry in numbers, venture and more. You can also follow their news section to stay in the picture on biotech, they even have their own magazine called “Insights” committed to highlighting the finest achievements in Canadian biotechnology.
BIOTECanada’s website: https://www.biotech.ca/
CANADIAN GENERIC PHARMACEUTICAL ASSOCIATION (CGPA)
CGPA member companies produce more than 70% of the prescription medicines dispensed in Canada. Through manufacturing facilities in Canada and the global supply chain, CGPA members directly employ 11,000 Canadians in well-paying life-sciences, technology, and manufacturing jobs.
Their webpage does not provide us with much interesting content, we can mention their news section, where you can follow the development in the field of generic pharmaceuticals. This association published a quick brochure analyzing how Canada’s generic drug pricing compares to a selection of international markets, that’s basically all from their website.
CGPA’s website: https://canadiangenerics.ca/
Some of the most important laws
Basic legislation
This is the cornerstone of the Canadian health care system, you can view it online or dowload it, accessible also in French.
This is the primary legislation that regulates the sale and importation of drugs in Canada.
Under these regulations, specific requirements for pharmacovigilance are outlined.
Guidelines
Good Pharmacovigilance Practices (GVP) Guidelines
These Guidelines (GUI-0102) provide detailed instructions for drug establishments on how to monitor and report ADRs effectively. They also ensure that all market authorization holders adhere to best practices in pharmacovigilance.
Local pharmacovigilance specifics
Useful abbreviations to know
If you want to study local materials about pharmacovigilance in Canada, following terms will be helpful for you to get familiar with:
DPD (Drug Product Database)
→ official database from Health Canada
MHPD (Marketed Health Products Directorate)
→ oversees the safety and effectiveness of health products
Is Qualified Person Responsible for Pharmacovigilance needed?
In Canada, a QPPV is not explicitly mandated by law. However, having a QPPV is considered a best practice for pharmaceutical companies to ensure compliance with Health Canada’s pharmacovigilance requirements.
This role encompasses responsibilities such as collecting, evaluating, and reporting adverse drug reactions (ADRs), monitoring drug safety data, and ensuring that all pharmacovigilance activities are in line with local regulations.
How can be adverse events reported in Canada?
To submit a report, you can use the electronic reporting form available on Canada Health’s website. This form allows you to report suspected ADRs related to medicines. It is also possible to report via email, fax or phone.
Health care professionals are obliged to report adverse drug reactions occurring in Canada to Marketed Health Products Directirate.
Local medical journals to screen
Here are few examples of Canadian local literature that medical authorization holders should monitor:
CANADIAN MEDICAL ASSOCIATION JOURNAL (CMAJ)
The CMAJ is a leading peer-reviewed medical journal that publishes original research, commentaries, etc., making it essential for healthcare professionals who want to stay informed.
Its commitment to integrating patient voices into its content makes it a unique platform.
ISSN: 0820-3946
CANADIAN MEDICAL EDUCATION JOURNAL (CMEJ)
The CMEJ focuses on medical education research and innovation, providing insights into teaching practices, curriculum development, and assessment methods in Canadian medical schools.
It’s a valuable resource for educators and students looking to improve medical education and training.
ISSN: 1923-1202
CANADIAN JOURNAL OF PUBLIC HEALTH (CJPH)
The CJPH publishes research related to public health issues affecting Canadians, including health policy, epidemiology, and health promotion strategies.
It serves as an important resource for public health practitioners and researchers aiming to improve health outcomes in communities across Canada.
ISSN: 1920-7476
CANADIAN JOURNAL OF INFECTIOUS DISEASES AND MEDICAL MICROBIOLOGY (CJIDMM)
The CJIDMM specializes in infectious diseases and microbiology, offering research articles, case reports, and reviews that are crucial for healthcare professionals dealing with infections.
Its focus on clinical practice guidelines helps practitioners stay updated on best practices in managing infectious diseases.
ISSN: 1918-1493
CANADIAN JOURNAL OF HEALTH HISTORY
This journal explores the history of health and medicine in Canada, providing insights into how historical events have shaped contemporary health practices and policies.
It’s particularly useful for historians, researchers, and anyone interested in understanding the evolution of healthcare in Canada.
ISSN: 2816-6477
Rather then spending your budget for hours of repetitive manual work to monitor those sources, we recommend to simply automate this task using our Tepsivo Literature solution.
Other interesting resources
Health Canada's annual report
All annual reports can be found under the link above, these reports are detailing how well provincial and territorial health care insurance plans meet the criteria for payment.
Scientific publications regarding pharmacovigilance
This study explores the potential of the Canada Vigilance program as a valuable resource for drug safety research, revealing key insights into the data available on anticoagulants and beta-blockers. With thousands of reported adverse reactions and a mix of data quality, readers will discover whether this database can truly support academic investigations into medication safety.
Reveal how the real-world costs and risks of adverse drug reactions (ADRs) can differ dramatically from what we learn in clinical trials, using two popular medications as case studies.
With this scientific material you can dive into the rising reports of clozapine-induced gastrointestinal hypomotility (CIGH) in Canada over 25 years, revealing alarming trends and potential risks, particularly among older patients. Readers will find intriguing insights into how certain medications might relate to fatal outcomes and why more research is essential to better understand and manage this serious condition.
interesting resources
This page contains basic staticsits about Canada in various fields such as Population, Life expectancy or Health statistics.
Data on basically everything regarging human health at glance. You can either see it in graphs or visit their infographic section. There are also Health Reports, which is a peer-reviewed journal that shares important research on population health and health services. Each month, it features timely articles based on national and provincial surveys.
Do you need some help with putting the Canadian PV System together? We’re here for you.
And while you’re here…
…consider also our global end-to-end PV solution!
Thanks to the Tepsivo platform, you can get a full pharmacovigilance system in all countries you need – for a fraction of the usual budget.
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