Canada is undertaking one of the most significant transformations of its clinical trials regulatory environment in more than two decades. This modernization initiative, which is currently open for public consultation, reflects the evolving complexity of medical products, the increasing use of digital and decentralized trial elements, and the need for regulatory agility in a rapidly changing research landscape.
The proposed Clinical Trials Regulations, together with new and updated guidance documents, are designed to strengthen participant protections while supporting innovation and reducing administrative burden. Below is an overview of what is being proposed, why modernization is needed, and how these changes are expected to improve clinical trial conduct across Canada.
Scope and What Is Being Consulted
Health Canada is seeking feedback on two major components:
Proposed Clinical Trials Regulations
These new regulations would apply to clinical trials involving drugs—including pharmaceuticals, biologics, and radiopharmaceuticals. Industry and stakeholders are invited to submit comments through Canada Gazette, Part I.
Draft Guidance Documents
To support implementation, Health Canada has released several draft guidance documents, including:
- Guidance on preparing and filing Clinical Trial Applications (CTAs/CTA-As)
- Guidance on SGBA+ and demographic action plans in clinical trial submissions
- Draft guidance (GUI‑0100) that interprets obligations under the proposed Regulations
Feedback can be submitted online or via email.
Deadline:
April 19, 2026
Why Modernize?
Several factors highlight the need for an updated, flexible regulatory framework:
One-size-fits-all requirements create an unnecessary burden
Not all trials carry the same level of risk, yet current regulations often treat them uniformly. This can disproportionately burden sponsors and slow study start-up.
Innovative trial designs require flexibility
Adaptive trials, platform trials, and decentralized trial elements are increasingly used, but these models need adaptable oversight.
Therapeutic innovation has outpaced the regulatory model
Complex biologics, radiopharmaceuticals, advanced therapeutics, and personalized medicines require tailored, risk‑based regulatory approaches.
Digital tools and data are transforming trial conduct
Remote monitoring, e‑consent, decentralized visits, real‑world data, and AI-enabled tools are now common in modern trials.
Global trials demand international alignment
Harmonization with like‑minded regulators can reduce duplication, strengthen compliance, and support strong Canadian participation in multinational trials.
Expected Results of Modernization
The modernization initiative is designed to enable more efficient and risk-proportionate reviews, thereby reducing the administrative burden on sponsors while preserving robust safety protections. It seeks to strengthen adaptive, risk-based oversight throughout the clinical trial lifecycle, ensuring that regulatory approaches remain flexible and responsive to evolving trial designs. Additionally, the initiative aims to improve timely access to clinical trials for Canadians, and enhance alignment with international guidelines to support greater Canadian participation in multinational studies.
Key Modernized Requirements at a Glance
The proposed Regulations introduce several transformative changes:
- Direct regulation of clinical trial conduct
- Risk-based regulatory approach, including Terms & Conditions (T&Cs)
- Updated CTA requirements
- Optional use of a National Research Ethics Board
- Expanded pool of eligible investigators (e.g., nurse practitioners)
- Flexibility in documenting informed consent
- Updated sponsor obligations
- Reduced record-keeping for low‑risk drugs with well‑understood safety profiles
- Modernized Compliance & Enforcement tools
- Direct oversight of service providers
- Ability to suspend or revoke only part of an authorization
Risk-Based Approach
Proposed measures include:
- Tailored requirements for approved drugs used off‑label
- Authority to impose or amend T&Cs
- Ability to partially revoke or suspend an authorization
Intended outcomes
To provide improved oversight for innovative drugs and complex trial designs, ensuring that regulatory requirements are more proportionate to the level of risk involved. By tailoring the requirements and compliance measures, the approach aligns with international best practices, fostering a more efficient and responsive regulatory environment.
Changes to CTA Requirements
Key proposed updates:
- Reduced requirements for lower‑risk drugs
- Mandatory inclusion of certain foreign REB or regulatory decisions
- Alignment with ICH E19 for selective recording of adverse events
- In specific cases, use of a Product Monograph instead of an Investigator’s Brochure
Authorization Process: Default and Extended Timelines
A contingent authorization will be provided within seven days following receipt of a complete CTA package, with default approval after 30 days unless an NSN is issued. For complex trials, the review period may be extended to a maximum of 60 days (applicable only to CTAs).
National REB Option
Sponsors may opt to obtain ethics approval through designated National Research Ethics Boards, enabling fewer REB reviews for multi-site trials and faster trial start-up across Canada
Expanded Scope of Investigators
Investigators may include other regulated health professional with relevant expertise. Medical decisions remain under physician supervision.
Flexibility for Informed Consent
Shift from “written” to “documented” informed consent and allowances for medical emergency exceptions to better support decentralized and remote trial participation
Sponsors’ Obligations: Notifications and Safety Information
Sponsors must notify Health Canada within 15 days of specified changes, including REB negative decisions and service provider updates.
Health Canada may require case reports, summary reports and/or post‑trial safety monitoring.
Modernized Compliance & Enforcement
Enhancements include: The oversight of service providers, the authority to act on systemic non‑compliance and continued application of GCP to all individuals involved in a trial.
Implementation Timeline
- Dec 20, 2025: Publication of proposed Regulations in Canada Gazette I
- 2026: What Was Heard report
- Spring 2027: Final Regulations in Canada Gazette II
- Spring 2028: Coming-into-force
Next Steps for Stakeholders
To review the proposed Regulations and guidance and provide written comments with section references to flag operational impacts and areas requiring greater clarity. The feedback should be submitted by April 19, 2026
Learn more or get involved
Questions? Contact:
bpsip‑bpspiconsultation@hc‑sc.gc.ca