Types of research with cannabis
The purpose of this page is to help you decide what cannabis licence you may need for a research study.
On this page
- Research studies
- Research studies involving human participants
- Other types of research studies
- Contact information
- Related links
Disclaimer: You need to read these pages along with the Cannabis Act and its Regulations. If there are differences, the Act and its Regulations are correct. If there are differences between this page and the Cannabis Tracking and Licensing System (CTLS), this page is correct.
To conduct research and development with cannabis, you may need to apply for a research licence. Refer to the Cannabis licensing application: Research licence for more information on research licence applications.
If you have a cannabis drug licence or a licence for cultivation, processing or analytical testing, you are already authorized to conduct certain research activities. These activities must be within your authorized licensed activities according to the Cannabis Regulations. If you want to conduct research outside of your authorized licence activities, you need to apply for a separate research licence.
For more information on research activities, refer to the Types of cannabis and industrial hemp licences web page.
Research studies involving human participants
You can refer to the decision tree below to help decide what type of cannabis licence you may need. You can find more information about each type of study below. If you have questions about the type of licence you may need, please refer to the Contact information section.
Types of research studies involving human participants
There are 3 types of research studies with cannabis involving human participants:
- non-therapeutic research on cannabis (NTRC)
- clinical trials
- observational studies
NTRC and clinical trials are both interventional studies where researchers administer and distribute cannabis to study participants. NTRC studies investigate non-therapeutic effects of cannabis, while clinical trials can investigate therapeutic and non-therapeutic effects of cannabis.
Therapeutic effects can include:
- the diagnosis, treatment, mitigation or prevention of a disease, disorder or abnormal physical state, or its symptoms
- the restoration or correction of organic functions in humans
Non-therapeutic research on cannabis (NTRC)
NTRC are interventional, non-therapeutic studies with cannabis regulated under the Cannabis Act and its Regulations.
The purpose of NTRC is to:
- increase the knowledge on cannabis and its non-therapeutic effects
- gain knowledge to inform public health and public safety measures, public education, and policy
- further research and development of cannabis products
An example of an NTRC study is assessing participants in a driving simulation test to find out how long they're impaired for after researchers have administered cannabis.
If you want to conduct an NTRC study, you need to apply for a research licence under the Cannabis Act and its Regulations. For the NTRC application requirements, refer to the Cannabis licensing application: Research licence web page.
Clinical trials with cannabis are interventional studies regulated under the Food and Drugs Regulations (FDR).
Clinical trials aim to gather evidence to help bring new therapeutic products to market or inform clinical practice. Researchers may use them to:
- discover or verify the therapeutic effects of cannabis
- understand how the human body processes cannabis
- find out the safety and efficacy of cannabis
An example of a clinical trial with cannabis could include studying whether a specific form of cannabis could ease pain.
These questions can help you decide if your research study may be a clinical trial:
- Is the intent of the study to discover or verify the effects of cannabis for therapeutic purposes?
- Are there factors that would exclude the study from the NTRC framework? (for example, participants younger than 18 years of age)
- Is the intent to use the study results to help apply for a market authorization under the FDR?
If you answer 'yes' to any of these questions, your study may be a clinical trial under the FDR.
If you want to conduct a clinical trial with cannabis, you will need both:
- a No Objection Letter (NOL) from the Office of Clinical Trials (OCT)
- a cannabis research licence from the Controlled Substances and Cannabis Branch (CSCB)
For more information on clinical trials with cannabis, please see the Notice to stakeholders – Clarification of requirements Under the Food and Drug Regulations when conducting clinical Trials with cannabis.
Important: You can choose to apply for and conduct studies on cannabis for non-therapeutic purposes under the Cannabis Act and its Regulations as NTRC or under the Food and Drugs Act (FDA) and its Regulations as clinical trials. However, you will need to meet all applicable requirements specific to the regulatory framework you choose. If the study involves conditions only the FDA and its Regulations permit, you must continue the study under that framework (for example, studies involving investigational drugs or pediatric patients).
Observational studies are non-interventional studies with cannabis that are limited to recording observations and analyzing data. These types of studies do not require approval from Health Canada. A researcher conducting an observational study is not permitted to conduct any authorized activities with cannabis including possessing and administering cannabis to participants.
While you do not need authorization from Health Canada to conduct observational studies with cannabis, you should make sure to check with your Research Ethics Boards about applicable ethics requirements.
An example of an observational study could be asking participants to fill out a questionnaire on how they felt after consuming cannabis products that:
- are available on the legal, regulated market or under the cannabis for medical purposes framework; and,
- they decided to consume or their health-care professional recommended.
Other types of research studies
Research studies for veterinary purposes
For research studies to be conducted using a veterinary drug, the objective is to ensure that there is appropriate oversight for the overall health and safety of study animals.
In order to conduct veterinary drug research using drugs containing cannabis, the investigator or the sponsor is required to submit an Experimental studies certificate (ESC) application to Health Canada's Veterinary Drugs Directorate (VDD). If the study includes food-producing animals, Health Canada also considers relevant information to address food safety. Depending on the details of the study being considered, you may need to obtain other authorizations from Health Canada before you begin.
For any questions or information about veterinary drug research involving cannabis, contact email@example.com.
Contact us if you have any questions about:
- cultivation, processing or sale for medical purposes licences: firstname.lastname@example.org
- analytical testing, research (including NTRC) or cannabis drug licences: email@example.com
- Date modified: