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

Regulatory authorities

Health Canada has regulatory authority over the sale and importation of drugs (pharmaceutical, biologic and radiopharmaceutical), medical devices and natural health products (NHPs) used for conducting clinical trials or investigational testing involving human participants. This authority is established under the Food and Drugs Act (act) and its regulations.

Under the Clinical Trials for Medical Devices and Drugs Relating to COVID-19 Regulations, we have authority over the:

conduct of the trial
sale and importation of the drugs or medical devices for the purpose of a clinical trial

Drug and NHP trials are grouped according to "phases":

Phase 1 clinical trials test an experimental product on a small group of people for the first time. The purpose is to:

look at the drug's safety
find a safe dose range
see if there are any side effects

In phase 2 clinical trials, the drug is given to a larger group of people (usually 100 or more) to:

gather data on how well the drug works to treat a disease or condition
obtain information on the drug's safety on a wider range of people
determine the best dose going forward

In phase 3 clinical trials, the drug is given to even larger groups of people (usually 1,000 or more) to:

determine if it is effective in the treatment of the condition under study
monitor side effects
compare it to commonly used treatments
collect information about the drug that will allow it to be used safely on the market

Phase 4 clinical trials take place after the drug is authorized and on the market. These trials often include safety studies and studies designed to support optimum use of the drug under its authorized conditions of use (for example, indication, population, dosage regimen). These clinical trials examine how drugs work in the real world and they can include larger, more diverse populations over long periods of time.

Drugs

Part C, Division 5 of the Food and Drug Regulations (FDR) requires the filing of a Clinical Trial Application (CTA) for:

drugs not yet marketed in Canada, including phases 1, 2, and 3 of drug development
marketed drugs used outside their Canadian market authorized conditions of use, such as different:
- indication
- population
- dosage regimen
comparative bioavailability studies (used in generic drug development)

Phase 4 clinical trials involve drugs used in clinical trials according to their Canadian market authorized conditions of use and do not usually require the filing of a CTA.

Sponsors of COVID-19 drug clinical trials may choose to file their CTA under the Division 5 regulatory pathway or in accordance with the Clinical Trials for Medical Devices and Drugs Relating to COVID-19 Regulations.

Health Canada reviews the CTA to determine if:

there is sufficient information to enable an assessment that the:
- objectives of the clinical trial are achievable
- use of the drug is not contrary to the best interests of the participant
- use of the drug in the clinical trial will not endanger the health of the clinical trial participant or other person
the information and documents were provided in accordance with the FDR

The regulations give us the authority to object to a trial that does not meet regulatory requirements, rather than authorizing one that does. Drug trial applications meeting regulatory requirements are issued a No Objection Letter.

A clinical trial site is the location where trial-related activities are conducted. Under Part C, Division 5 of the FDR, the sponsor must obtain approval from a properly constituted research ethics board (REB) before the trial may begin at each clinical trial site.

All clinical trials (including phase 4) must be conducted in accordance with good clinical practice principles.

Guidance document for clinical trial sponsors: Clinical trial applications

Medical devices

Part 3 (sections 79 to 88) of the Medical Devices Regulations (MDR) governs the sale and importation of a medical device for investigational testing involving human participants. The submission of an Investigational Testing Authorization (ITA) application is required to sell or import a Class II, III or IV medical device for the purpose of conducting investigational testing.

Manufacturers, as defined in section 1 of the MDR, and importers must meet the regulatory requirements therein, including requirements outlined in subsections 80(2) and 83(1). A Letter of Authorization is issued for medical devices if all regulatory requirements have been met in the ITA application. This allows a device to be sold to a qualified investigator for the purpose of conducting investigational testing.

As per Section 6 of the MDR, medical devices are classified into one of 4 classes where Class I represents the lowest risk and Class IV the highest.

Under section 80 of the MDR, the manufacturer or importer must possess the records specified in section 81 before the sale of the medical device for investigational testing, including:

device label
patient consent form
investigational testing protocol
information on the investigators involved
written approval from the institution indicating that investigational testing may be carried out there
risk assessment comprising an analysis and evaluation of the risks associated with the use of the device being tested

The MDR also sets out requirements to be followed post-authorization including:

recalls
labelling
advertising
implant registration
foreign risk notification
incident reporting procedures
complaint handling procedures
maintaining distribution records

Manufacturers of COVID-19 medical device clinical trials may choose to file their application under Part 3 of the MDR or in accordance with the Clinical Trials for Medical Devices and Drugs Relating to COVID-19 Regulations.

Applications for medical device investigational testing authorizations guidance document

Natural health products

Clinical trials investigating NHPs are regulated under Part 4 of the Natural Health Products Regulations (NHPR). These trials may be conducted to provide further information about a product including its safety and efficacy. More precisely, Part 4 of the NHPR is to ensure:

the safety, efficacy and quality of the study's:
- clinical trial protocol
- investigational product(s)
- placebo or comparator
the safety of clinical trial participants and other people
compliance with good clinical practices (section 74)
that people with suitable expertise conduct properly designed clinical trials

In general, the requirements for clinical trials under the NHPR are similar to the clinical trial requirements for drugs. However, the NHPR recognize that NHPs may differ from single chemical entities in both manufacturing and evaluating processes.

A Notice of Authorization is issued for NHP trials if all regulatory requirements have been met in the trial application.

Guidance document for clinical trials for natural health products

Glossary

Clinical trial: A study, involving human subjects, for the purpose of discovering or verifying the effects of a drug, a device or a food for a special dietary purpose. (Food and Drugs Act)

Although this is the regulatory definition, this guidance document uses the term "participants" for "subjects".

Also note that while pharmaceuticals, biologics, radiopharmaceuticals and natural health products (NHPs) are classified as drugs under the act, NHPs are described separately in this guidance document to provide clarity for stakeholders.

Clinical trial application: The information required by Health Canada from sponsors seeking authorization to sell or import a drug or NHP for the purpose of a clinical trial, or a medical device for the purpose of investigational testing, involving human participants.

Device: An instrument, apparatus, contrivance or other similar article, or an in vitro reagent, including a component, part or accessory of any of them, that is manufactured, sold or represented for use in:

diagnosing, treating, mitigating or preventing a disease, disorder or abnormal physical state, or any of their symptoms, in human beings or animals
restoring, modifying or correcting the body structure of human beings or animals or the functioning of any part of the bodies of human beings or animals
diagnosing pregnancy in human beings or animals
caring for human beings or animals during pregnancy or at or after the birth of the offspring, including caring for the offspring or
preventing conception in human beings or animals

however, it does not include such an instrument, apparatus, contrivance or article, or a component, part or accessory of any of them, that does any of the actions referred to in paragraphs (a) to (e) solely by pharmacological, immunological or metabolic means or solely by chemical means in or on the body of a human being or animal. (Food and Drugs Act)

Note: "Medical device" means a device within the meaning of the act, but does not include any device that is intended for use in relation to animals. (Medical Devices Regulations)

Drug: Includes any substance or mixture of substances manufactured, sold or represented for use in:

the diagnosis, treatment, mitigation or prevention of a disease, disorder or abnormal physical state, or its symptoms, in human beings or animals
restoring, correcting or modifying organic functions in human beings or animals, or
disinfection in premises in which food is manufactured, prepared or kept (Food and Drugs Act)

While pharmaceuticals, biologics, radiopharmaceuticals and natural health products (NHPs) are classified as drugs under the act, NHPs are described separately in this guidance document to provide clarity for stakeholders.

Good clinical practices: Generally accepted clinical practices that are designed to ensure the protection of the rights, safety and well-being of clinical trial participants and other persons, and the good clinical practices for drug trials referred to in section C.05.010 of the FDRand NHP trials referred to in Part 4, section 74 of the NHPR. There is no applicable reference in the MDR.

Certain general practices are set out in the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH)-E6 Guideline. Additional practices are set out in the International Organization for Standardization (ISO) 14155 for medical devices.

Natural health product: A substance set out in Schedule 1 or a combination of substances in which all the medicinal ingredients are substances set out in Schedule 1, a homeopathic medicine or a traditional medicine, that is manufactured, sold or represented for use in:

the diagnosis, treatment, mitigation or prevention of a disease, disorder or abnormal physical state or its symptoms in humans
restoring or correcting organic functions in humans or
modifying organic functions in humans

However, a natural health product does not include a substance set out in Schedule 2, any combination of substances that includes a substance set out in Schedule 2 or a homeopathic medicine or a traditional medicine that is or includes a substance set out in Schedule 2.

A substance or combination of substances or a traditional medicine is not considered to be a natural health product if its sale, under the FDR, is required to be pursuant to a prescription when it is sold other than in accordance with section C.01.043 of those regulations. (Natural Health Products Regulations)

Register and registration: The act of placing information about a clinical trial into an electronic repository.

Registry: An electronic repository of information about ongoing or completed clinical trials. Most registries are public facing, allowing interested parties including patients and healthcare professionals to search for and read the clinical trial records. Some include summaries of results.

Research ethics board: While there is no regulatory definition under the MDR, both the FDR and NHPR share similar definitions. The FDR definition is:

A body that is not affiliated with the sponsor, and:

the principal mandate of which is to approve the initiation of, and conduct periodic reviews of, biomedical research involving human subjects in order to ensure the protection of their rights, safety and well-being and
that has at least 5 members, that has a majority of members who are Canadian citizens or permanent residents under the Immigration and Refugee Protection Act, that is composed of both men and women and that includes at least
1. 2 members whose primary experience and expertise are in a scientific discipline, who have broad experience in the methods and areas of research to be approved and one of whom is from a medical discipline or, if the clinical trial is in respect of a drug to be used for dental purposes only, is from a medical or dental discipline
2. 1 member knowledgeable in ethics
3. 1 member knowledgeable in Canadian laws relevant to the biomedical research to be approved
4. 1 member whose primary experience and expertise are in a non-scientific discipline and
5. 1 member who is from the community or is a representative of an organization interested in the areas of research to be approved and who is not affiliated with the sponsor or the site where the clinical trial is to be conducted

Sell: Includes:

offer for sale, expose for sale or have in possession for sale, or distribute to 1 or more persons, whether or not the distribution is made for consideration and
lease, offer for lease, expose for lease or have in possession for lease (Food and Drugs Act)

Sponsor: An individual, corporate body, institution or organization that conducts a clinical trial. (Food and Drug Regulations), (Natural Health Products Regulations)

For this guidance document, the term "sponsor" will also refer to authorization holders for investigational testing under the MDR.

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2026-07-28