Health Canada Proposes To Exempt Certain Low-risk Non-prescription Drugs From “New Drug” Requirements

On May 15, 2026, Health Canada issued a Notice of Intent to publish a Ministerial Order that would exempt certain low-risk NPDs from the requirements of Division 8 of Part C (New Drugs) of the Food and Drug Regulations (“FDR”). As a result, low-risk non-prescription drugs (“NPDs”) that have not been previously authorized in Canada may soon benefit from a less onerous pathway to market under Health Canada’s proposed Ministerial Class Exemption Order (the “Order”).

Health Canada is inviting stakeholder feedback on the proposed approach, with comments due by July 14, 2026.

Currently, drugs containing medicinal ingredients not previously authorized in Canada are regulated as “new drugs” under Part C, Division 8 of the FDR. Both prescription and non-prescription drugs are subject to the same rules. Even lower-risk NPDs, including those intended for cosmetic-like purposes (e.g., sunscreens, anti-dandruff products, and oral care products), must meet the same rigorous requirements as prescription drugs, which includes significant data requirements, review timelines of up to 300 days, and costs that may exceed $600,000 to obtain market authorization.

Understanding Health Canada’s intent

Health Canada’s stated intent of the Order is to remove barriers that limit the range of options available to treat common conditions, as well as to simplify and accelerate market access for certain low-risk NPDs containing ingredients that are new to Canada but have demonstrated safety and efficacy in other jurisdictions. Although an expedited pathway already exists for certain NPDs that align with existing Health Canada monographs, this pathway is not available for products containing medicinal ingredients not previously authorized in Canada, even where such ingredients have been considered safe in other jurisdictions.

Under the proposed Order, low-risk NPDs listed on List D (List of Certain Non-prescription Drugs for Distribution as Samples), including acne therapy products, anti-dandruff products, antiperspirants, antiseptic skin cleansers, athlete’s foot treatments, diaper rash products, medicated skin care products, oral health products (e.g., toothpastes and mouthwashes), throat lozenges, and sunscreens, would be exempt from ”new drug” requirements, provided they comply with an applicable Health Canada monograph.

Over time, Health Canada plans to update its monographs to include additional medicinal ingredients, which could expand the range of low-risk NPDs that can use this exemption. This approach could reduce the regulatory burden and associated costs, including reducing if not eliminating additional data requirements, shortening review timelines, and significantly lowering authorization costs.

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