Regulatory innovation for health products: Modernizing clinical trial regulations
On this page
- Current state of regulatory process for clinical trials
- Our plan
- Implications from COVID-19
- Opportunities for comment
- Contact us
Current state of regulatory process for clinical trials
Clinical trials are an important step in health product development. As products evolve, so do clinical trial types and designs. Clinical trial studies increasingly focus on individualized treatments rather than larger patient groups. New technologies are also changing the way we conduct studies.
Modernizing clinical trial regulations will help improve access to novel therapies, while safeguarding patient safety. Our proposed approach will focus on:
- enabling proportional oversight to:
- establish the appropriate requirements for certain trials based on risk
- use terms and conditions to manage uncertainties and mitigate risks
- adopt a proportional, risk-based approach for the inspection of clinical trials
- establishing new transparency measures to improve:
- international alignment
- 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
- support oversight for clinical trials throughout their lifecycle
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
- medical device investigational testing
These changes aim to:
- support access to innovative treatments
- provide Canadians with greater opportunities to participate in a broader range of clinical trials
Industry and academics will benefit from flexible, clear and predictable regulatory requirements and streamlined approaches. There will be greater public access to clinical trial information and trial participants will benefit from improved safety monitoring.
Implications from COVID-19
On May 3, 2021, the Minister of Health signed a second interim order for clinical trials for medical devices and drugs related to COVID-19. The new interim order replaces the original signed on May 23, 2020, and continues to support the optional pathway to facilitate clinical trials for potential COVID-19 drugs and medical devices.
The new interim order continues to streamline the investigation of potential therapies and facilitates broader access for Canadians to COVID-19 related investigational drugs and medical devices. An interim order is one of the fastest mechanisms available to address large-scale public health emergencies, without following the usual regulatory process.
Under the interim order, Health Canada is reducing the administrative burden for sponsors applying to conduct a COVID-19 clinical trial, while maintaining patient safety and the validity of trial results. It is also introducing flexibility by expanding the types of health care professionals who can conduct a clinical trial. Further information can be found in the interim order notice.
Opportunities for comment
Health Canada sought feedback on the Clinical Trials Regulatory Modernization Initiative. The feedback received during the consultation will be used to better inform decision-making with respect to outstanding proposed regulatory, policy, and program considerations for each of the product lines.
Health Canada published a "What we heard" report summarizing the comments received during the spring and summer 2021 consultation process.
- Agile lifecycle approach
- Risk-based approach
- Use of new authorities – terms and conditions
- Compliance and enforcement approach
The consultation paper and online questionnaire includes human drugs, medical devices, non-prescription drugs, and natural health products.
Stakeholders will also be able to comment on the regulatory proposal during the Canada Gazette, Part I, public comment period. Timelines can be found on Health Canada's Forward Regulatory Plan.
John Patrick Stewart
Therapeutic Products Directorate
Health Products and Food Branch
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