Health Canada Proposing to Modernize the Regulatory Framework for Clinical Trials

Health Canada Proposing to Modernize the Regulatory Framework for Clinical Trials

June 11, 2021 By

In May of 2021, Health Canada announced a proposal to modernize the regulatory framework for Clinical Trials.

This proposal hopes to help improve support the introduction of novel safe and effective therapies to the Canadian market, improving the lives of Canadians while giving them access to vital information to help them make better informed decisions about their health. The COVID-19 Pandemic has precipitated an unprecedented regulatory response by Health Canada in order to make sure Canadians had access to needed health products. That resulted in a roadmap to enhance the agility of the health product regulatory framework, making regulations more adaptive to innovation while maintaining rigorous safety standards.

Since 2017, Health Canada has initiated a range of regulatory modernization initiatives. Following a targeted Regulatory Review of the health and bio-sciences sector, Health Canada consulted a broad range of stakeholders to achieve greater regulatory agility. These initiatives will be introduced in 5 areas:

  1. Modernizing clinical trial regulations,
  2. Enabling Advanced Therapeutic Products,
  3. Agile licensing for drugs,
  4. Agile licensing for medical devices; and,
  5. Information to Canadians through mobile strategy.

Health Canada plans to enhance the agility of the health product regulatory framework and make regulations more adaptive to innovation which would result in tangible results such as:

  • Encouraging clinical trials in Canada to be more innovative,
  • Enhancing patient access to new and innovative health products,
  • Advancing timely access to drugs and devices.

The plan mentioned above will provide agility to respond to innovation and provide opportunities to reduce regulatory burden where there are lower risks to health and safety.

Some of the items proposed on the agenda include:
  • Revising the regulations streamlining the review and issuance of Drug Establishment Licences
  • Amending the regulations to modernize Medical Device Establishment License obligations and develop modern compliance and enforcement tools
  • Reducing the current record retention requirements from a minimum of 25 years to a minimum of 15 years to reduce the regulatory burden on the industry

Health Canada is also planning a new concierge service to support innovation. This service will be conducted by providing a single point of contact for external stakeholders related to the Advanced Therapeutic Products (ATP) pathway. This service will also be done through an active, engaging plan with innovators, including hospitals and international counterparts.

What was also identified was that the traditional oversight model may have deterred some clinical trials being conducted in Canada and hence would have constrained innovation/growth across product lines. The road map of supporting innovation hopes to alleviate this by creating a more modern regulatory system, increasing alignment with international regulators, and enabling a low-cost market authorization pathway to help foster economic growth. The modernization mentioned above would attract more clinical trials to come to Canada with the knowledge of dealing with a supportive and innovative environment.

A Public Consultation for This Initiative is Currently Open till July 4, 2021:

This initiative is currently open for public consultation which means that anyone, including industry and non-industry, or any otherwise interested Canadian, is invited to provide their feedback. If you wish to do so, feel free to access Health Canada’s official website for the initiative here, where you can learn more about the initiative, read the consultation paper, and provide your feedback via their online questionnaire or by email, whichever way is most convenient.

If you have any questions related to this initiative or any other regulatory affairs matter, please contact dicentra using the form below, and feel free to access the following related resources.