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

HOW DOES HEALTH CANADA’S CLINICAL TRIAL APPLICATION PROCESS COMPARE TO THE SUBMISSION PROCESSES IN THE US OR 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.

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

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

HOW HAS THE EVOLUTION OF REGULATORY AFFAIRS AFFECTED THE WAY CLINICAL TRIALS ARE CONDUCTED NOW VERSUS 10 YEARS 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.

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

DOES CANADA RANK FAVOURABLY AS A GOOD CHOICE TO CONDUCT 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 type of Market Protection exists for new Drugs in Canada?

WHAT TYPE OF MARKET PROTECTION IS APPLICABLE IN CANADA AND HOW DOES IT APPLY?

All drug products containing a new chemical entity are eligible to an eight-year period of market exclusivity. Should the drug product be aimed for a pediatric population, a further six-month extension can apply if the acceptable pediatric data are submitted within the first 5 years of the 8-year period. Health Canada will conduct a preliminary assessment while the drug is under review (NDS) and the sponsor will be notified of the outcome.

Consequently, a subsequent-entry manufacturer is not allowed to file a submission for a generic drug for the first six years of the eight-year period. For products with eligible patents, submission of patent forms within the planned NDS and SNDS is critical to avoid loss of rights and generic entries to the market earlier than the market allows.

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