What we heard: Consulting on modernizing clinical trials
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Modernizing the clinical trial regulations
Health Canada is committed to streamlining processes and making the regulatory process more efficient. Together with the Public Health Agency of Canada, we identified initiatives and actions we can take to remove regulatory red tape, without undermining the core purpose of regulations to protect health and safety.
Read our report on reducing red tape.
We consulted with interested parties on proposed new regulations related to clinical trials:
- Clinical Trials Regulations (CTR)
- Regulations Amending Certain Regulations Relating to Clinical Trials
We also consulted on 3 draft guidance documents associated with the new regulations:
- Draft guidance on clinical trial applications for clinical trial sponsors
- Draft guidance on proposed new Clinical Trials Regulations (GUI-0100)
- Draft guidance document for clinical trial sponsors: SGBA plus demographics action plan in clinical trial applications
Learn about this consultation.
These proposed regulations and draft guidance documents were published in the Canada Gazette, Part I.
The consultation period was from December 20, 2025, to April 19, 2026.
The CTR will replace the following current regulations:
- Part C, Division 5 of the Food and Drug Regulations and
- Part 2 of the Clinical Trials for Medical Devices and Drugs Relating to COVID-19 Regulations
The proposed regulations will improve access to new and innovative therapies for people in Canada while maintaining strong safety protections for participants.
Who we consulted
A wide range of interested parties, from industry and research networks, to foreign regulatory agencies, took part.
Interested parties provided their feedback through multiple channels, such as an online questionnaire, email and the regulatory consultation online system.
In total, we received 214 unique responses:
- anonymous – 52 (24%)
- individuals – 48 (23%)
- research networks, academics and hospitals – 47 (22%)
- industry – 41 (19%)
- patient safety and advocacy organizations – 10 (5%)
- research ethics boards – 5 (2%)
- federal, provincial and territorial governments – 5 (2%)
- health care professional associations – 3 (1%)
- foreign regulatory authorities – 2 (1%)
- other – 1 (1%)
We also held 4 engagement sessions with interested parties between January 29 and February 5, 2026. About 500 people attended.
Submissions were comprehensive, detailed and ranged from a few paragraphs to many pages.
What we heard
In general, respondents support efforts to modernize the clinical trial regulations.
Respondents indicated how we could be more competitive globally, improve operations and deliver clinical trials more efficiently.
Many comments we received focused on specific parts of the proposed regulations, such as the:
- proposed list of national research ethics boards (REBs)
- extending the review timeline from 30 to 60 days under certain circumstances
- ability to impose terms and conditions (T&Cs)
- lack of specific exemptions for certain low-risk trials
Key themes
The feedback we received can be grouped into 3 themes:
- Regulatory changes
- Clarifications
- Ideas for future regulatory reform
Theme 1: Regulatory changes
National research ethics boards (REBs) and governance
- 129 comments
We received a wide range of views on the proposed concept. Those who are supportive see opportunities for greater ethics oversight and accreditation, and more streamlined ethics reviews. Others are concerned about the ability to put the concept into operation and noted the possible misalignment with institutional accountability and provincial regulations. Some respondents recommend using mutual recognition agreements instead.
Respondents said there's a need for REB standards and accreditation, as well as greater ethics oversight. There were also comments about the composition of REBs.
In general, interested parties called for:
- clearer expectations
- more streamlined reliance pathways
- practical implementation supports and
- Health Canada to take a more active role in protecting human health research
Review timelines and competitiveness
- 76 comments
Respondents are especially concerned about extending the review timeline from 30 to 60 days under certain circumstances.
Many from industry said this could negatively affect Canada's global competitiveness and ability to attract clinical research. They said the criteria for such extensions should be more clearly defined and narrowly applied (for example, for T&Cs). This would minimize potential impacts on complex trials and studies involving vulnerable populations.
Terms and conditions (T&Cs)
- 52 comments
Most respondents who commented about T&Cs are not opposed to Health Canada imposing them on an authorization. They did say there should be narrower criteria and a more defined process and timeline.
Contingent authorization
- 47 comments
Many stakeholders are confused about the concept of a contingent authorization, including its value from a legal and operational perspective, since it wouldn't allow any trial-related activities to begin.
Theme 2: Clarifications
Guidance clarity
- 88 comments
Many respondents suggested changes to wording in the draft guidance documents to make them clearer and more practical. They also suggested how to improve the structure, and asked for more examples and better-defined expectations.
Questions on roles, definitions and processes
- 66 comments
We received questions about some definitions in the regulations (for example, service provider and investigator). Respondents also asked for more details on the processes for informed consent and decentralized trials.
Questions on regulatory requirements
- 50 comments
Respondents want more information on various requirements under the proposed regulations to avoid unintended burdens. These requirements include labelling, reporting adverse drug reactions and notifications.
Theme 3: Ideas for regulatory reform
Participant protection
- 70 comments
Health Canada received some additional comments about the need to implement mandatory national REB standards and quality and accreditation requirements. They said these measures could support governance, better protect participants and broaden ethical oversight to cover the entire trial.
These proposals are beyond the scope of this regulatory package.
Risk-based oversight and exemptions
- 48 comments
Some academic and pediatric health care respondents strongly advocated for further risk-based exemptions. They said such exemptions would reduce the regulatory burden for low-risk clinical trials that use Canadian-authorized drugs either off-label or to further evaluate current treatments.
Scope and product lines
- 32 comments
Some respondents are disappointed the proposed regulations are limited to drugs. They said previous Health Canada consultations had suggested other investigational products, such as medical devices and natural health products, would be included.
Next steps
We're carefully reviewing the feedback as we work on finalizing the proposed regulations and draft guidance documents.
We're considering the concerns identified under theme 1 and will provide more clarity on the issues raised under theme 2.
While the suggestions identified under theme 3 are not part of the current phase of regulatory reform, they will be considered in the future.
We expect to publish the final version of the regulations in the Canada Gazette, Part II, in spring 2027, followed by a one-year coming-into-force period.