Canada: Regulatory Trends – Canada

Last Updated: June 26 2014
Article by Andrew Loh

Most Read Contributor in Canada, September 2016

I. Canada's Food & Drugs Act – Major Changes Proposed

In Canada, the sale and marketing of pharmaceuticals, biologics, medical devices and other healthcare products are regulated under the Food & Drugs Act and regulations. Since the creation of this legislation in the 1950's, it has remained virtually unchanged. However, things are about to change.

Due to increased publicity and litigation over Health Canada's failure to warn the public about the dangers of certain drugs, particularly when the same dangers were raised by the World Health Organization and foreign regulatory authorities a few years earlier, concerns over insufficient detection and management of potential safety issues caused legislators to re-examine the current legislation for the purpose of strengthening Health Canada's regulatory powers.

Bill C-17, also known as the Protecting Canadians from Unsafe Drugs Act or Vanessa's Law, was formed. Bill C-17 proposes taking a 'product life-cycle' approach to the regulation of health products. What this means is that a health product's risks and benefits will not only be assessed before the product enters the Canadian market but also continually after it has entered the market. Health products subject to such assessments will be prescription and over-the-counter drugs, radiopharmaceuticals, vaccines and other biologics, gene and cell therapies, and medical devices, but not natural health products. Another major change is to give Health Canada the ability to order a recall of an unsafe drug, because under the current legislation, drug recalls are undertaken voluntarily by manufacturers and distributors.

Other proposed major changes include:

  • Stronger requirements for adverse reaction reporting (including requiring health care institutions to report serious adverse drug reactions and medical device incidents to Health Canada)
  • Giving Health Canada greater powers to demand and obtain safety information
  • Allowing Health Canada to pursue faster regulatory action when a serious health risk is identified, including the right to order a product recall or a change to the product's label to make new safety information available
  • Imposing stiffer fines and penalties to reflect the seriousness of the violation – up to a maximum of $5,000,000 and/or 2 years' imprisonment (from the current $5,000 fine and/or 3 years' imprisonment)

II. Risk Management Plans – Proposed Requirements

In keeping with adopting a 'product life-cycle' approach to assessing the risks and benefits of a health product, Health Canada requires sponsors/market authorization holders to provide risk management plans. A risk management plan is a dynamic, stand-alone document that is to be updated throughout a product's life cycle and contains descriptions of pharmacovigilance activities and interventions designed to identify, characterize, prevent or minimize risks related to medicinal products, as well as an assessment of the effectiveness of those interventions.

In recognizing that risk management planning has become a global activity, Health Canada has indicated that it will accept the EU format that adheres to the "Notice Regarding Implementation of Risk Management Planning including the adoption of International Conference on Harmonisation (ICH) Guidance Pharmacovigilance Planning – ICH Topic E2E". Health Canada will also accept the U.S. Risk Evaluation and Mitigation Strategies (REMS) as long as the essential risk minimization elements outlined in the EU format are covered. Even though the use of an EU and a US format is acceptable, Health Canada has indicated that where special considerations exist with respect to medical practice or populations in Canada, the sponsor/market authorization holder must address the special Canadian context in its risk management

plan. A risk management plan should include all available post-market data (if marketed in Canada or elsewhere) in the form of an annual summary report or a periodic safety update report. The plan should also provide a rationale in situations where additional pharmacovigilance (e.g. a drug utilization study, registry) or risk minimization activities (e.g. contraindication, restricted distribution) are proposed or implemented outside of Canada even if it is not proposed or implemented in Canada.

A risk management plan is required to be submitted for a drug, biologic or radiopharmaceutical that is intended for human use, in the following circumstances:

  • as part of a new drug submission
  • when a serious safety issue has been identified
  • when a previously acceptable risk management plan has undergone significant changes
  • significant change in what is known about the risks and benefits or in the frequency or severity of a known risk or the identification of a previously unknown risk

III. Orphan Drugs

With over 7,000 rare diseases identified in Canada, an 'orphan drug' regulatory framework is currently under development in Canada. A 'product life-cycle' approach will also be taken to assess the risks and benefits of an orphan drug both before and after market entry into Canada.

Applicants seeking 'orphan drug' designations for their drugs must demonstrate all of the following:

  • prevalence of the disease in Canada is less than 5 in 10,000
  • the severity of the disease
  • the medical plausibility of the drug
  • a lack of existing therapy or potential for significant improvement

Adherence to a risk management plan, a pharmacovigilance plan, a commitment to carry out confirmatory studies, and the implementation of quality controls will be conditions that must be satisfied in order to obtain and maintain market authorization for the orphan drug in Canada.

About BLG

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.

To print this article, all you need is to be registered on

Click to Login as an existing user or Register so you can print this article.

In association with
Related Video
Up-coming Events Search
Font Size:
Mondaq on Twitter
Register for Access and our Free Biweekly Alert for
This service is completely free. Access 250,000 archived articles from 100+ countries and get a personalised email twice a week covering developments (and yes, our lawyers like to think you’ve read our Disclaimer).
Email Address
Company Name
Confirm Password
Mondaq Topics -- Select your Interests
 Law Performance
 Law Practice
 Media & IT
 Real Estate
 Wealth Mgt
Asia Pacific
European Union
Latin America
Middle East
United States
Worldwide Updates
Check to state you have read and
agree to our Terms and Conditions

Terms & Conditions and Privacy Statement (the Website) is owned and managed by Mondaq Ltd and as a user you are granted a non-exclusive, revocable license to access the Website under its terms and conditions of use. Your use of the Website constitutes your agreement to the following terms and conditions of use. Mondaq Ltd may terminate your use of the Website if you are in breach of these terms and conditions or if Mondaq Ltd decides to terminate your license of use for whatever reason.

Use of

You may use the Website but are required to register as a user if you wish to read the full text of the content and articles available (the Content). You may not modify, publish, transmit, transfer or sell, reproduce, create derivative works from, distribute, perform, link, display, or in any way exploit any of the Content, in whole or in part, except as expressly permitted in these terms & conditions or with the prior written consent of Mondaq Ltd. You may not use electronic or other means to extract details or information about’s content, users or contributors in order to offer them any services or products which compete directly or indirectly with Mondaq Ltd’s services and products.


Mondaq Ltd and/or its respective suppliers make no representations about the suitability of the information contained in the documents and related graphics published on this server for any purpose. All such documents and related graphics are provided "as is" without warranty of any kind. Mondaq Ltd and/or its respective suppliers hereby disclaim all warranties and conditions with regard to this information, including all implied warranties and conditions of merchantability, fitness for a particular purpose, title and non-infringement. In no event shall Mondaq Ltd and/or its respective suppliers be liable for any special, indirect or consequential damages or any damages whatsoever resulting from loss of use, data or profits, whether in an action of contract, negligence or other tortious action, arising out of or in connection with the use or performance of information available from this server.

The documents and related graphics published on this server could include technical inaccuracies or typographical errors. Changes are periodically added to the information herein. Mondaq Ltd and/or its respective suppliers may make improvements and/or changes in the product(s) and/or the program(s) described herein at any time.


Mondaq Ltd requires you to register and provide information that personally identifies you, including what sort of information you are interested in, for three primary purposes:

  • To allow you to personalize the Mondaq websites you are visiting.
  • To enable features such as password reminder, newsletter alerts, email a colleague, and linking from Mondaq (and its affiliate sites) to your website.
  • To produce demographic feedback for our information providers who provide information free for your use.

Mondaq (and its affiliate sites) do not sell or provide your details to third parties other than information providers. The reason we provide our information providers with this information is so that they can measure the response their articles are receiving and provide you with information about their products and services.

If you do not want us to provide your name and email address you may opt out by clicking here .

If you do not wish to receive any future announcements of products and services offered by Mondaq by clicking here .

Information Collection and Use

We require site users to register with Mondaq (and its affiliate sites) to view the free information on the site. We also collect information from our users at several different points on the websites: this is so that we can customise the sites according to individual usage, provide 'session-aware' functionality, and ensure that content is acquired and developed appropriately. This gives us an overall picture of our user profiles, which in turn shows to our Editorial Contributors the type of person they are reaching by posting articles on Mondaq (and its affiliate sites) – meaning more free content for registered users.

We are only able to provide the material on the Mondaq (and its affiliate sites) site free to site visitors because we can pass on information about the pages that users are viewing and the personal information users provide to us (e.g. email addresses) to reputable contributing firms such as law firms who author those pages. We do not sell or rent information to anyone else other than the authors of those pages, who may change from time to time. Should you wish us not to disclose your details to any of these parties, please tick the box above or tick the box marked "Opt out of Registration Information Disclosure" on the Your Profile page. We and our author organisations may only contact you via email or other means if you allow us to do so. Users can opt out of contact when they register on the site, or send an email to with “no disclosure” in the subject heading

Mondaq News Alerts

In order to receive Mondaq News Alerts, users have to complete a separate registration form. This is a personalised service where users choose regions and topics of interest and we send it only to those users who have requested it. Users can stop receiving these Alerts by going to the Mondaq News Alerts page and deselecting all interest areas. In the same way users can amend their personal preferences to add or remove subject areas.


A cookie is a small text file written to a user’s hard drive that contains an identifying user number. The cookies do not contain any personal information about users. We use the cookie so users do not have to log in every time they use the service and the cookie will automatically expire if you do not visit the Mondaq website (or its affiliate sites) for 12 months. We also use the cookie to personalise a user's experience of the site (for example to show information specific to a user's region). As the Mondaq sites are fully personalised and cookies are essential to its core technology the site will function unpredictably with browsers that do not support cookies - or where cookies are disabled (in these circumstances we advise you to attempt to locate the information you require elsewhere on the web). However if you are concerned about the presence of a Mondaq cookie on your machine you can also choose to expire the cookie immediately (remove it) by selecting the 'Log Off' menu option as the last thing you do when you use the site.

Some of our business partners may use cookies on our site (for example, advertisers). However, we have no access to or control over these cookies and we are not aware of any at present that do so.

Log Files

We use IP addresses to analyse trends, administer the site, track movement, and gather broad demographic information for aggregate use. IP addresses are not linked to personally identifiable information.


This web site contains links to other sites. Please be aware that Mondaq (or its affiliate sites) are not responsible for the privacy practices of such other sites. We encourage our users to be aware when they leave our site and to read the privacy statements of these third party sites. This privacy statement applies solely to information collected by this Web site.

Surveys & Contests

From time-to-time our site requests information from users via surveys or contests. Participation in these surveys or contests is completely voluntary and the user therefore has a choice whether or not to disclose any information requested. Information requested may include contact information (such as name and delivery address), and demographic information (such as postcode, age level). Contact information will be used to notify the winners and award prizes. Survey information will be used for purposes of monitoring or improving the functionality of the site.


If a user elects to use our referral service for informing a friend about our site, we ask them for the friend’s name and email address. Mondaq stores this information and may contact the friend to invite them to register with Mondaq, but they will not be contacted more than once. The friend may contact Mondaq to request the removal of this information from our database.


This website takes every reasonable precaution to protect our users’ information. When users submit sensitive information via the website, your information is protected using firewalls and other security technology. If you have any questions about the security at our website, you can send an email to

Correcting/Updating Personal Information

If a user’s personally identifiable information changes (such as postcode), or if a user no longer desires our service, we will endeavour to provide a way to correct, update or remove that user’s personal data provided to us. This can usually be done at the “Your Profile” page or by sending an email to

Notification of Changes

If we decide to change our Terms & Conditions or Privacy Policy, we will post those changes on our site so our users are always aware of what information we collect, how we use it, and under what circumstances, if any, we disclose it. If at any point we decide to use personally identifiable information in a manner different from that stated at the time it was collected, we will notify users by way of an email. Users will have a choice as to whether or not we use their information in this different manner. We will use information in accordance with the privacy policy under which the information was collected.

How to contact Mondaq

You can contact us with comments or queries at

If for some reason you believe Mondaq Ltd. has not adhered to these principles, please notify us by e-mail at and we will use commercially reasonable efforts to determine and correct the problem promptly.