Does Health Canada require all documents be translated to French?


Does Health Canada require that all documents be translated to French?




Not at all. Both official languages in Canada, that is English and French, are accepted. That being said, the regulatory dossiers are usually submitted to Health Canada in English. French dossiers, or the supporting documents that are in French, are also acceptable, however, the review could be a little more challenging since most of the Health Canada reviewers are Anglophone. Even if it is not required to submit French documents to Health Canada, the French translation of the informed consent form must be generated and available for francophone patients. Also, there are specific language regulations to respect on Canadian labels. That being said, Health Canada has established standard target review timelines that they respect, which is not influenced by the selected submission language.


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Are Sponsors required to have a legal representative reside in Canada?


Does Health Canada require Sponsors to have a legal representative reside in Canada?




A scientific or medical officer residing in Canada that represents the sponsor and who’s responsible for providing an attestation with respect to the clinical trial application or the amendment that is being filed, is required. There is no additional information available in the regulations or guidance related to the Canadian officer. Therefore, any Canadian scientific personnel that are authorized by the sponsor to submit the application on their behalf and to be the representative can be the signatory. Normally the regulatory agent or the CRO can sign the clinical trial application on behalf of the sponsor.

With respect to having Sponsors having a legal representative residing in Canada for the Registration Process, the answer is no, Health Canada does not require Canadian residence. Nonetheless, if the sponsor is not located in Canada, a Canadian importer must be determined and their Drug Establishment License (DEL) submitted or amended at least 3 months prior to the submission of the marketing authorization submission (NDS or ANDS) in Canada. This is one of the Good Manufacturing Practice requirements.

That being said, having a Canadian regulatory point of contact in Canada is an advantage for the Canadian regulatory language with Health Canada as well as for dealing rapidly with questions and being in the same time zone as the reviewing regulatory agency.


For questions about the Canadian Drug Review & Regulatory approval process that is not covered in this section, please go ahead and contact us directly.


The importance of working with Canadian Regulatory Consultants

The Importance of working with Canadian regulatory experts.



Having a Canadian regulatory expert is important to facilitate the global Canadian submission process and all post-approval activities. It’s also important to know that Health Canada prefers speaking with individuals that understand the Canadian medical as well as regulatory environment, whether they are the sponsors or their representatives. The support of a Canadian regulatory consultant is key for the submission of clinical trial applications, New Drug Submissions, or other regulatory initiatives. But it is most important for the global product development strategy, particularly when dealing with niche products used for treating orphan or life-threatening diseases. By understanding Canadian as well as foreign regulatory environments, a Canadian consultant can provide the best strategic initiative for timely access to the Canadian market, keeping the global regulatory initiatives in mind.

The regulatory paths for market access in Canada are essentially threefold. First there is the standard regulatory new drug submission path, then there is the notice of compliance with conditions (NOC/c) path, usually applicable for oncology or other niche products, and finally there is the priority review path. The latest two have shorter review standards at Health Canada.



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How does Canada’s Application process compare to USA and EU?

How does Health Canada’s Clinical Trial Application process compare to the USA and EU?



When the process is properly understood and the sponsor or the representatives have established contacts with Health Canada, the clinical trial application in Canada is relatively simple and so is the review process. The actual submission structure is also simple, and the content requirements are actually less than in the US and Europe.

There are no non-clinical, nor clinical study reports needed in the clinical trial application. What is needed is the administrative documents plus key scientific documents, which are the protocol, the informed consent form and the investigators brochure. There’s two Canadian specific templates required that we need to generate: the protocol summary as well as the overall quality summary. All of these are quite easy to prepare.

The review process is also efficient. A 30-day default review period applies. If questions are raised during the dossier review a response must be provided within two calendar days (exceptions may apply). And by way of comparison, in Canada there is no clinical hold period like in the United States. The review period is always 30 days, whereas in some European countries the review period can be as long as 60 days or more, and in the US it can vary.

Due to the standard 30-day review period in Canada, I believe it does facilitate the ethics review submission planning, which speeds up clinical trial start times. Also, there are efficient clinical trials start-up experts in Canada that can help with streamlining the study start-up process in parallel or after the clinical trials application approval.

Are Health Canada’s safety policies and guidelines more stringent than those imposed by the FDA?

The requirements are similar in Canada and in the U.S. for clinical trial applications as well as for post-approval initiatives.


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Covid-19 Coronavirus Clinical Trials in Canada


Covid-19, Coronavirus Clinical Trials in Canada

With the pandemic of Covid-19 continuing across the globe, pharmaceutical companies, scientists, hospitals and health care organizations around the world continue to accelerate clinical research to find a treatment and possible vaccine. In Canada, the number of Covid-19, coronavirus clinical trials has been steadily growing.

As of May 1st, 2020, there were 29 active Clinical Trials operating in Canada focused on Covid-19. (See the report below).

Although Clinical Trials take time, we expect further growth over the next few months in the number of Clinical Trials for Covid-19 in Canada and around the world. We will publish any updates as data of new Clinical Trials are made available.

Health Canada has published certain guidelines as it pertains to the management of clinical trial applications (CTA) during the Covid-19 pandemic. Such guidelines include:

  • Health Canada will prioritize the review of clinical trial applications designed to investigate the diagnosis, treatment and/or prevention of COVID-19.
  • Sponsors may continue to file other CTA and CTA amendments according to Health Canada guidance.
  • During the course of a CTA review, if sponsors are unable to respond to an Information Request (IR) within specified time lines, consider withdrawing the submission without prejudice and refiling when the information is available.

Please visit Health Canada’s information page for further details on their guidelines for clinical trials during the Covid-19 pandemic.

Download the Covid-19 Clinical Trial in Canada summary report

We have co-published a report on Covid-19 Clinical Trials in Canada with our friends at the Clinical Research Organization (CRO) McDougall Scientific. We have taken clinical trial data for Canada directly from provided by the National Institutes of Health and published a summary of the data in a format that is hopefully useful to digest.

Some of the data provided includes:

  • # of Covid-19 Clinical Trials by Canadian Province
  • # of Covid-19 Clinical Trials by Sponsors/Collaborators
  • # of Covid-19 Clinical Trial by Drug Interventions


How does Canada rank as a country for conducting Clinical Trials?


 How does Canada rank as a country for conducting Clinical Trials?




We know we can’t compete in terms of population, but Canada does have numerous strengths, making it a very attractive host for early phase clinical trials. These strengths include highly trained clinicians, the presence of key opinions leaders, world-class investigators, renowned medical care standards and a well-diversified population, all of which are desirable for testing new drugs. In addition, Canada is one of the top countries for biomedical research productivity and international reputation.

Recognized worldwide for its research excellence and the quality of its research clinicians, Canada has proven to be a world-class location for pharmaceutical and medical device companies to conduct their clinical trials. In fact, the majority of the world’s top pharma companies choose Canada as one of their top clinical trial locations.

We recommend that drug developers come to Canada early in their drug development process, for many reasons.

First of all, we have expert physicians in various therapeutic fields, key opinion leaders with internationally renowned reputations, that are clearly interested in participating in Canadian clinical trials. In addition, we have efficient regulatory experts, CROs and clinical trial start-up facilitators helping with the Canadian process efficiency.

Adding Canadian sites to a multi-centre trial is a great initiative to expose expert physicians as well as patients to novel therapies that will eventually come to market, raising interest, awareness and knowledge. The fact that the Canadian population is very similar to that of the US, makes Canada an interesting extension of the U.S. initiative for patient recruitment.  This way, our Canadian population can benefit from these novel therapies, while adding to the global clinical trial recruitment initiative.

In addition, the Canadian regulatory agency provides a decision within an efficient standard review of 30 days. Also, early Canadian initiative can build the health authorities’ confidence with a sponsor and product by raising awareness, interest and knowledge. This can translate into facilitating the accelerated access to the Canadian market, should the product meet the requirements.

Should the drug be innovative and / or life-saving, we would recommend a strategic registration regulatory strategy, because of the possibility of having a faster approval granted either during the clinical trial phases or immediately upon completion. A meeting with Health Canada would be recommended to validate the strategy, secure agreements that would be part of meeting minutes, included in the upcoming registration initiative.

According to the Government of Canada, the country captures 4% of global clinical trials, is also fourth in number of clinical trial sites and has a world-class contract research sector with extensive capabilities in phase I-IV clinical trials.

Canada is regarded as a leader in scientific research due to a number of factors including the diversity of its population, its educated labour force, world leading universities, hospitals and research centers as well as its robust health care system. In addition, Canadian universities consistently rank among the top in the world. Educational rankings worldwide continue to place the University of Toronto, McGill University, University of British Columbia and McMaster University in the top 50 Universities in the world for medical research.

Designing and managing global clinical trials has large expense considerations. Independent studies continue to show Canada as having significant cost advantages as a location for clinical trials. KPMG’s Competitive Alternatives study, for instance, compares business costs and other competitiveness factors in more than 100 cities in ten major countries, puts Canada as 2nd as the country with the lowest business costs. The US is 10th. On a per city basis, Montreal, Toronto and Vancouver were ranked 3rd, 4th and 5th respectively. Most of the cities in the US were ranked in the 20s.

Whether it is patient diversity, the industry’s reputation, its infrastructure, it’s quality researchers, it’s cost competitiveness or Health Canada’s 30 day target to review Clinical Trial Applications, these advantages lead pharmaceutical companies and research institutions to continue making significant investments in Canadian clinical research.





For questions about the Canadian Drug Review & Regulatory approval process that is not covered in this section, please go ahead and contact us directly.


What adjustments are made for Targeted Therapeutics?


What adjustments do drug developers make associated to Targeted Therapeutics?




The key adjustments for drug developers have been to increase transparency with the authorities and open up to pre-submission or scientific advice meetings. These meetings become even more efficient when you bring in local experts and key opinion leaders.

The purpose of this is to discuss strategies and requirements with the authorities and to come up with agreements for the drug development activities. Meeting with Health Canada is not a requirement, but it’s highly recommended for novel therapies that would not have the same clinical data package that would usually be required or expected in Canada for market access.

With regards to submission content, contrary to common belief, Health Canada follows similar requirements to those of the FDA and EMA, therefore, usually only minor adjustments are necessary from a FDA or EMA dossier when submitting a marketing application in Canada.



For questions about the Canadian Drug Review & Regulatory approval process that is not covered in this section, please go ahead and contact us directly.


Has Regulatory Affairs in Canada changed from a decade ago?

How has Regulatory Affairs in Canada changed from a decade ago?




With regards to clinical trial applications, Health Canada’s requirements have not changed much. However, they’ve had no choice but to open up to new strategies – novel agents, personalized medicines, or orphan drugs for which there is no official designation yet – and accept novel trial designs. Health Canada is very open to hear how novel therapies can help Canadians and there’s a clear openness and opportunity for collaboration.



For questions about the Canadian Drug Review & Regulatory approval process that is not covered in this section, please go ahead and contact us directly.


Will Health Canada approve Trials with multiple investigational products?

Will Health Canada approve Clinical Trials designed with more than one investigational product?



Yes, definitely. With the appropriate quality information for both investigational products, Health Canada will review the dossier and approve it if it meets the Canadian requirements, and that will be under the same 30-day default review period.


For questions about the Canadian Drug Review & Regulatory approval process that is not covered in this section, please go ahead and contact us directly.


Does Health Canada prefer early phase or late phase trials?


Does Health Canada prefer early phase trials or late phase studies close to approval?




Health Canada is very open to all phases of clinical trials for both early and late phase. If the product is innovative or has the potential of being granted an NOC/c, we do recommend that sponsors meet with Health Canada early to ensure that the study trial design and the clinical development plan is aligned with the requirements for an accelerated access to market.


For questions about the Canadian Drug Review & Regulatory approval process that is not covered in this section, please go ahead and contact us directly.