Guidance on the registration of clinical trials and public disclosure of results: Overview

Effective: July 29, 2026

On this page

• Purpose
• Scope and application
• Policy objectives
• Policy statements
• Background
• Note about guidance documents in general

Purpose

Health Canada is the federal regulator responsible for the regulation of clinical trials involving a wide range of health products, including:

• drugs that are:
  • biologics
  • pharmaceuticals
  • radiopharmaceuticals
• medical devices
• natural health products (NHPs)

Clinical trials are an important step in health product development. They are essential for the development of new treatment options and support early and safe access to health innovations.

Increasing transparency around clinical trials facilitates public access to clinical trial information. This may result in improved recruitment by informing interested persons about trials that are taking place. This includes those who identify with population groups that are often under-represented in clinical trials, such as:

• women
• Indigenous Peoples
• ethnic and racialized groups

Increasing transparency may also increase public trust and confidence in the safety and efficacy of health products, and inform where further research is needed.

Scope and application

This guidance document applies to sponsors of clinical trials that are regulated under the Food and Drugs Act (act) and its regulations, including:

• clinical trials for phases 1 through 3 of drug development
• clinical trials for phases 1 through 3 of NHP development
• clinical trials (also known as investigational testing) for Class II to IV medical devices

The following are not part of the scope of this guidance document:

• comparative bioavailability studies
• clinical trials designed as single patient trials, also known as open label individual patient (OLIP) trials
• clinical trials for phase 4 development of drugs and NHPs used within the parameters of their marketing authorization
• clinical trials involving Class I devices and licensed devices used within the parameters of their marketing authorization

Although the definition of "drug" in the act includes NHPs, they are described separately in this guidance document to provide clarity for stakeholders.

Policy objectives

This policy aims to increase transparency of clinical trials regulated in Canada and help the public access information on clinical trials by addressing elements related to:

• registration
• public disclosure of results (summary results reporting)
• access

Policy statements

With the aim of increasing transparency of Canadian clinical trials, sponsors are expected to register their clinical trial:

• ideally before it has opened for enrolment in Canada but
• not later than 21 calendar days after the date of enrolment of the first participant

Registration should be with a clinical trial registry that complies with the international standards set by the World Health Organization (WHO).

Additionally, sponsors are expected to submit the summary results of their clinical trial to the same registry where the sponsor first registered the trial. The information included in the summary results is considered summary information and does not include individual patient data.

• Sponsors should submit the summary results of their clinical trial within 12 months following primary study completion. Primary study completion means the final study visit for collection of data on the primary outcome for the last participant in the global study.
• Sponsors should keep their clinical trial information up to date with the registry. This includes submitting any outstanding summary results information within one year of study completion (last participant last visit).

Health Canada will publish select information from the international clinical trial registry records to our Canadian Clinical Trial Search Portal along with weblinks to those records. Doing so will make this information more accessible to the public.

Background

Health Canada is advancing the modernization of its clinical trial regulations to better serve stakeholders, while continuing to protect the safety of clinical trial participants.

We conducted consultations on a proposed clinical trials modernization initiative. The feedback received supports mandatory registration and reporting of results, with the strongest support for requirements that are aligned internationally.

Stakeholder feedback, established international standards and the clinical trial authorities that came into force under the act on May 23, 2020, support Health Canada in taking initial steps towards regulating clinical trials transparency.

The policy expectations described in this guidance document serve as a preparatory step, before Health Canada would propose regulations for clinical trial registration and reporting of summary results. Policy expectations are recommendations that are strongly advised but not required by law, giving stakeholders the opportunity to develop or augment existing practices associated with registration and results reporting.

Note about guidance documents in general

Guidance documents provide assistance to industry and health care professionals on how to comply with governing statutes and regulations. They also provide guidance to Health Canada staff on how mandates and objectives should be met fairly, consistently and effectively. Guidance documents are administrative, not legal, instruments. This means that flexibility can be applied.

This guidance document uses "must" to describe a regulatory requirement or other obligation under the law that, where unfulfilled, would result in a direct consequence or non-compliance activity. "Should" and "expect" are used to describe a recommendation that is strongly advised but not required by law at the time of publication of the guidance document.

This document should be read in conjunction with the accompanying notice and the relevant sections of other applicable guidance documents.