September 16, 2026
Cannabis Research Rules Are Being Rewritten: The Fall 2026 Gazette Window
By Mussarat Fatima

Cannabis research in Canada is getting easier to start, and the rules that govern it are still moving. In March 2025, Health Canada removed the research licence requirement for certain small scale, non-human and non-animal work. Now a further set of amendments aimed at facilitating cannabis research is working its way toward the Canada Gazette, with a public comment window expected in the fall of 2026. For licensed producers, contract research organisations, analytical laboratories and academic researchers, this is a short, high leverage moment. The organisations that comment help shape the final rule. The ones that do not will simply inherit whatever it becomes.
This article explains what has already changed, what is coming, and how to position for it. It is written for the person deciding whether a project needs a research licence at all, and for the compliance lead who wants to be ready to comment when the Gazette window opens. If you want the step by step on obtaining a licence itself, our guide to the cannabis research licence in Canada covers that ground. Here, the focus is the regulatory change and the exemption most people have not fully absorbed.
Executive summary
What is changing, and when
In short: two things are in motion. First, a research exemption that is already in force, from March 2025, that removes the licence requirement for small scale non-human and non-animal work. Second, a further round of amendments to facilitate cannabis research that Health Canada expects to pre-publish in the Canada Gazette, Part I, with a public comment period anticipated in fall 2026. The first you can use now. The second you can influence soon.
The March 2025 change arrived through the Regulations Amending Certain Regulations Concerning Cannabis (Streamlining of Requirements), which came into force on 12 March 2025 and were published in the Canada Gazette, Part II. Those amendments touched several instruments at once, including the Cannabis Regulations and the Cannabis Exemption (Food and Drugs Act) Regulations, and were designed to reduce regulatory burden while keeping the public health and safety objectives of the Cannabis Act intact.
The next step is separate. Health Canada published a notice of intent on 30 August 2025, followed by a 60 day comment period, signalling amendments to the Cannabis Exemption (Food and Drugs Act) Regulations specifically to facilitate cannabis research. According to Health Canada's Forward Regulatory Plan, the formal proposal is expected to reach the Canada Gazette, Part I, with a public comment period, in fall 2026. Dates in a forward plan can slip, so treat fall 2026 as expected rather than fixed, and watch for the pre-publication.
Key dates
| Date | Milestone | Status |
|---|---|---|
| 12 March 2025 | Streamlining amendments in force, including the section 28.01 research exemption | In force |
| 30 August 2025 | Notice of intent on amendments to facilitate cannabis research, 60 day comment period | Complete |
| Fall 2026 (expected) | Canada Gazette, Part I pre-publication and public comment period | Anticipated, may shift |
| After Part I | Final regulations published in Canada Gazette, Part II | Future |
Section 28.01: when you do not need a research licence
In short: since 12 March 2025, section 28.01 of the Cannabis Regulations allows a person, other than a young person, to conduct cannabis research without a research licence if the work is non-human and non-animal, the total quantity of cannabis held for research does not exceed the equivalent of 30 grams of dried cannabis, and the research is not conducted in a dwelling-house or at an address on a registration certificate. This is a meaningful opening for laboratories and product developers doing early, small scale work.
The exemption also sets out what is and is not allowed. A person relying on it may produce cannabis for the research, and may use organic solvents, but may not cultivate, propagate or harvest cannabis, and may not administer or distribute cannabis to a human participant or to an animal. Cross those lines, whether by scaling past 30 grams, moving into human or animal administration, or cultivating your own plants, and a research licence is required again.
| Question | Section 28.01 exemption | Research licence |
|---|---|---|
| Human or animal administration? | Not permitted | Required for human or animal work |
| Quantity held for research | Up to 30 g dried equivalent | No 30 g ceiling |
| Cultivate, propagate or harvest? | Not permitted | Permitted under licence |
| Produce cannabis for the research? | Permitted | Permitted |
| Location | Not in a dwelling-house or a registered address | Per licence conditions |
The fall 2026 Gazette window and why it matters
In short: when a regulation is pre-published in the Canada Gazette, Part I, there is a defined public comment period before it is finalised in Part II. That window is the formal, on the record chance to influence the rule. For cannabis research, an expected fall 2026 Part I window means the sector has a short, scheduled opportunity to shape how the research amendments land.
A comment does not have to be adversarial to be useful. Regulators genuinely use well reasoned, evidence based submissions to refine definitions, thresholds and conditions. A short, specific comment that explains how a proposed provision would work at the bench, or where a threshold creates an unintended barrier, carries more weight than a general objection.
How to make a Canada Gazette comment count
- Read the proposal and the Regulatory Impact Analysis Statement in full, and note the exact provisions relevant to your work.
- Identify the specific clauses that help or hinder your research, and tie each comment to a clause.
- Support each point with concrete, non-confidential examples from real projects rather than general assertions.
- Propose alternative wording where you object, so the regulator has something concrete to adopt.
- Submit before the deadline, through the channel named in the Part I notice, and keep a copy for your records.
Who is affected
In short: the change reaches further than research licence holders. Health Canada has identified licence holders under the Cannabis Act and the provinces and territories as directly affected, but the practical impact lands on anyone doing or planning cannabis research, from analytical laboratories to product developers to universities.
- Licensed producers running internal research and development, who may be able to move some early work under the exemption rather than a separate licence.
- Contract research organisations and analytical laboratories, whose small scale, non-human method development may now fall under section 28.01.
- Academic and institutional researchers, for whom the 30 gram, non-human threshold removes a licensing step for a lot of foundational work.
- Anyone whose work will cross into human or animal study, who still needs a research licence and, for clinical work, must also meet clinical trial requirements.
That last point matters. The section 28.01 exemption is for non-human and non-animal research. The moment a project involves people, a different and more demanding framework applies, including the clinical trial rules and the disclosure expectations we cover in our article on Canada's clinical trials portal. Do not let an early stage exemption create a false sense of how light the requirements stay as a project grows.
Readiness checklist
Use this to decide where your project sits today and to prepare for the fall 2026 window.
- You have confirmed whether each current project is non-human and non-animal, and stays at or below the 30 gram dried equivalent.
- You have documented that no research is conducted in a dwelling-house or at a registered address.
- You have a clear internal rule for when a project crosses from exemption into licence territory.
- You hold a research licence, or a plan to obtain one, for any human, animal, cultivation or larger scale work.
- You have assigned someone to monitor the Canada Gazette, Part I for the cannabis research proposal.
- You have identified which provisions matter most to your work and gathered concrete examples to support comments.
- You have a drafting and sign off process ready so a comment can be submitted before the deadline.
- You have reviewed how the change interacts with your other cannabis obligations, from tracking to fees.
Common mistakes
In short: most errors here come from treating the exemption as broader than it is, or from missing the comment window entirely.
- Assuming the exemption covers any research, when it is limited to non-human and non-animal work under 30 grams.
- Reading the conditions individually rather than as a set that must all be met at once.
- Scaling a project past the exemption thresholds without re-checking whether a licence is now required.
- Waiting until the rule is final in Part II, when the time to influence it is the Part I comment window.
- Submitting a general objection with no clause references and no proposed wording.
- Forgetting that human or animal work triggers a different and more demanding framework.
Frequently asked questions
Do I need a research licence to do cannabis research in Canada?
Not always. Since 12 March 2025, section 28.01 of the Cannabis Regulations lets a person conduct non-human and non-animal cannabis research without a research licence, as long as they hold no more than the equivalent of 30 grams of dried cannabis, do not administer or distribute cannabis to a human participant or animal, and do not conduct the research in a dwelling-house or at a registered address. Work outside those limits still requires a licence.
How much cannabis can I hold for research without a licence?
Up to the equivalent of 30 grams of dried cannabis at any given time, provided the other conditions of section 28.01 are also met. The 30 gram equivalent is a ceiling on what you can possess for the research, not a per project or per year allowance.
Can I grow my own cannabis for research under the exemption?
No. A person relying on section 28.01 may produce cannabis for the research and may use organic solvents, but may not cultivate, propagate or harvest cannabis. Growing plants moves the activity outside the exemption and back into licensed territory.
When is the Canada Gazette comment window for the new research rules?
Health Canada's Forward Regulatory Plan indicates a Canada Gazette, Part I pre-publication with a public comment period expected in fall 2026, following a notice of intent published on 30 August 2025. Forward plan dates can move, so monitor Part I for the actual pre-publication and its stated deadline.
What is the difference between the exemption and a research licence?
The exemption is a narrow allowance for small scale, non-human, non-animal work under 30 grams, with no cultivation and no administration to people or animals. A research licence authorises a much broader set of activities, including cultivation and human or animal research, subject to licence conditions. Our cannabis research licence guide walks through the licence route.
Should we submit a comment during the Gazette window?
If the amendments could affect how you conduct research, yes. A specific, evidence based comment tied to particular clauses, with proposed wording where you object, is the most effective way to shape the final rule. Firms that comment help set the terms they will operate under.
How MFLRC can help
MFLRC helps cannabis licence holders, laboratories and researchers navigate exactly this kind of moving target. We provide section 28.01 applicability opinions, so you know whether a project needs a licence before you start. We support research licence applications and amendments, help you build the SOPs and records a licensed research programme needs, and draft Canada Gazette comment submissions that are specific, evidence based and tied to the clauses that matter to you. We also connect the change to your wider obligations, from the cannabis tracking system to red tape reduction and the 1 October 2026 harmonization changes, so nothing is managed in isolation.
If you are unsure whether your work qualifies for the exemption, or you want to be ready to comment when the fall 2026 window opens, a short strategy call is the fastest way to get clear on your position.
Conclusion
Cannabis research in Canada is being made easier on purpose, and the direction is set by whoever shows up. Section 28.01 already lets a lot of early, non-human work proceed without a licence, provided you respect its limits as a single set of conditions. The next round of amendments to facilitate research is expected to reach the Canada Gazette, Part I in the fall of 2026, and that window is the moment to influence the rule rather than inherit it. Know where your projects sit today, watch for the pre-publication, and be ready to say something specific when the window opens.
Sources and references
- Health Canada, Summary of changes following the streamlining of regulations (section 28.01, non-human and non-animal research)
- Canada Gazette, Part II, SOR/2025-43, Regulations Amending Certain Regulations Concerning Cannabis (Streamlining of Requirements)
- Justice Laws Canada, Cannabis Regulations (SOR/2018-144)
- Justice Laws Canada, Cannabis Exemption (Food and Drugs Act) Regulations (SOR/2016-231)
- Health Canada, Forward Regulatory Plan 2026 to 2028, amendments to facilitate cannabis research
Downloadable Resource
Cannabis Research Licence Decision Worksheet
A one page worksheet that helps you decide whether your project qualifies for the section 28.01 exemption or needs a research licence, plus a checklist to prepare for the fall 2026 Canada Gazette comment window.
File: MFLRC-Cannabis-Research-Decision-Worksheet.pdf
Fill in your details below and the download link will appear right away.
Share with others
Tags
