Earlier in June, Health Canada announced that it plans to modernize its clinical trial regulation framework to support the implementation of promising novel therapies and match the accelerating advances in technology. These changes have been announced as part of the Government of Canada’s Regulatory Innovation Agenda for health products.
According to Health Canada, modernizing clinical trial regulations will help to introduce novel safe and effective therapies to the Canadian market and meet the unique requirements of innovative treatments. These include personalized health products, gene therapies and therapies intended for the treatment of rare diseases.
“We’ll better align our clinical trial framework, including the compliance and enforcement approach, across affected business lines, including human drug clinical trials, natural health product clinical trials and medical device investigational testing,” states the Health Canada website.
Furthermore, the health regulator has also stated that the COVID-19 pandemic has demonstrated that the clinical trials regulatory framework needs further modifications.
“The Government of Canada was quick to respond to the pandemic by issuing the Interim Order respecting clinical trials for medical devices and drugs relating to COVID-19 (CT-IO) and the subsequent Interim Order No.2 respecting clinical trials for medical devices and drugs relating to COVID-19 (CT-IO 2), and their associated Guidance documents. […] Although the measures under the CT-IOs are temporary, they have also provided an important proof of concept for some of the elements of clinical trial modernization that were already under consideration.”
Specifically, Health Canada plans to introduce a coherent risk-based approach, including implementing greater flexibility in the safe development of innovative therapies, streamlining processes toward greater efficiency and clarity, and aligning with international best practices regarding oversight and public access to information.
The regulator is proposing a single clinical trials framework for all health products. According to Health Canada, these changes would allow “proportional risk-based oversight, new regulatory agilities over the lifecycle of the trial, greater transparency through registration and public disclosure of results and a modernized compliance and enforcement regime.”
In addition, these changes will permit industry and academics to benefit from the new flexible, clear and predictable regulatory requirements and streamlined approaches. Other modifications include increased public access to clinical trial information and improved safety monitoring for trial participants.
The Health Canada website states that the modernization plan also includes the following aspects:
- Enabling proportional oversight to establish the appropriate requirements for certain trials based on risk, use terms and conditions to manage uncertainties and mitigate risks and adopt a proportional, risk-based approach for the inspection of clinical trials
- Establishing new transparency measures to improve international alignment and public access to clinical trial information
- Enabling authorization of the clinical trial and product(s) within the trial to better accommodate new trial types and designs and support oversight for clinical trials throughout their lifecycle
- Better aligning the clinical trial framework, including the compliance and enforcement approach for human drug clinical trials, natural health product clinical trials and medical device investigational testing.
In addition, the agency is currently seeking public feedback on its Clinical Trials Regulatory Modernization Initiative.