PMPRB Releases Revised Draft Guidelines

A regulatory shift now under consideration in Ontario could reshape how the province’s medical aesthetic clinics operate. The proposal, which would change how nurses are authorized to administer medical aesthetic services, invites a broader look at how Ontario currently regulates cosmetic injections and how the proposed changes would align the province more closely with the regulatory frameworks already in place elsewhere in Canada. While these procedures are often marketed as routine “spa” services, they remain medical acts that involve prescription products and carry clinical risks.

These ailments are usually short-term conditions, which can be reliably self-diagnosed and managed with minor treatment and minimal follow-up care.

On July 29, 2026, Health Canada announced that it had obtained a permanent injunction against a Québec-based company in connection with the sale of unauthorized injectable peptides in Canada. The announcement reflects Health Canada’s continued focus on peptide products and serves as a reminder that injectable peptides intended for human use are regulated as prescription drugs and are subject to Canada's drug regulatory framework.

On Wednesday, the Natural Health Products Regulations amendments were published to the Canadian Gazette, Part II.

The Ontario Ministry of Health and Long-Term Care (Ministry) has proposed changes to Ontario's drug product formulary listing and pricing regime.

Health Canada issued revised guidance on notifying Health Canada of foreign actions, effective October 1, 2026. The revised guidance clarifies the requirements to notify Health Canada of certain foreign regulatory actions specified in subsection C.01.050(2) of the Food and Drug Regulations in the specified foreign jurisdictions, which involve a serious risk of injury to human health and are relevant to the safety of the drug.

The new framework effectively positions public drug and supplemental benefits plans as payers of last resort. Where a member is entitled to alternative coverage, that coverage must be accessed first, and the public plan will only pay in limited circumstances and only up to the unpaid portion of the claim.

Health Canada appears to be administratively reclassifying Class I Medical Devices as Class II based on product claims rather than the established Classification Rules that focus on invasiveness and activity level.

While not currently legally binding, the guidance sets clear expectations for clinical trial registration and results disclosure and signals Health Canada’s broader push for transparency in clinical research. Health Canada describes this policy-first approach as a way to allow sponsors to adapt before potential regulatory requirements are introduced. For sponsors conducting clinical trials in Canada, the announcement therefore represents more than the launch of a new public-facing tool, it provides an indication of the direction of Canada’s evolving clinical trial framework.

In June 2022, Health Canada introduced new nutrition labelling regulations for prepackaged foods. A key feature of these regulations is the mandatory use of a front-of-package (FOP) nutrition symbol...

Health Canada issued revised guidance on notifying Health Canada of foreign actions, effective October 1, 2026. The revised guidance clarifies the requirements to notify Health Canada of certain foreign regulatory actions specified in subsection C.01.050(2) of the Food and Drug Regulations in the specified foreign jurisdictions, which involve a serious risk of injury to human health and are relevant to the safety of the drug.

Health Canada is not currently meeting its performance standards for the review of some generic drug submissions. On September 1, 2026, Health Canada launched a new webpage, Improving how we review generic drugs, and released three notices on proposed actions to address the backlog of generic drug submissions under review.

Health Canada has secured a permanent injunction against Canlab Research, a Quebec-based online retailer, preventing the company from manufacturing, distributing, or selling unauthorized injectable peptides in Canada. This enforcement action follows years of regulatory warnings and provisional court orders aimed at stopping the illegal sale of peptide drugs promoted with unproven health claims for anti-aging, weight loss, and athletic performance.

COLD-FX is a top-selling natural health product in Canada, with sales topping nearly $120-million as recently as 2011, according to a November 15, 2015 Globe and Mail article, "Why COLD-FX is too good to be true".

Health Canada has announced significant regulatory changes for medical device establishment licensing, set to take effect in December 2026. These Phase II amendments aim to streamline requirements...

Brand and influencer collaborations are a key component in marketing products and services, as highlighted in our article on Like & Follow! What to know when #advertising with #influencers.

On December 20, 2023, the Federal Court issued a Notice to the Parties and the Profession regarding the use of artificial intelligence in court proceedings. In line with several other provincial

The Pharmaceutical and Life Sciences Sector Task Force has released its final report addressing Canada's challenges in medication access, regulatory processes, and life sciences competitiveness. The report examines structural issues including lengthy reimbursement pathways, underperforming clinical trial environments, and erosion of domestic investment, while proposing 39 recommendation areas to strengthen Canada's health sovereignty and industrial strategy.

For a Canadian patent application to be examined, an applicant must file a request for examination with the Canadian Intellectual Property Office (CIPO). In most cases, the order in which applications are examined is based on the order that the requests for examination are received. An applicant may be able to accelerate examination of their patent application through several existing mechanisms, including advancing examination via special order, accelerating examination of applications related to green technology, and the Patent Prosecution Highway (PPH).

As we previously reported, Health Canada consulted on the framework for clinical trials, including on the new Clinical Trials Regulations and draft and updated guidance documents. Health Canada has now published a What we heard overview of the results of the consultation.