Health Canada Launches Cost-Benefit Analysis Survey on Natural Health Product Red Tape Reduction

Health Canada has opened a cost-benefit analysis survey inviting natural health product companies and industry associations to gather input on how proposed regulatory changes would affect their business. The survey supports proposed amendments to the Natural Health Products Regulations (SOR/2003-196) intended to reduce regulatory burden for industry and government while maintaining oversight proportionate to risk.  

Stakeholders are invited to submit their responses by September 25, 2026. Submissions should be provided in Microsoft Word format, with a PDF accepted as an additional attachment, and emailed to the Office of Legislative and Regulatory Modernization at lrm.consultations-mlr@hc-sc.gc.ca.

What the Proposed Amendments Would Change 

The survey is built around a specific set of proposed regulatory amendments, not a general consultation on burden reduction. The proposed changes fall into four main areas:

1. A registration pathway for certain NHPs. Products that fully align with an existing Health Canada monograph, currently managed as Class I (compendial) applications, would move to a notification-based registration system rather than a licensing process. Under this approach, no pre-market review would be required before the product receives an NPN or DIN-HM and enters the market, and the current 60-day disposition period for monograph-based applications would be eliminated. Class II and III applications would continue to undergo the existing licensing review process.
2. Greater flexibility in post-market safety monitoring. The proposal would remove the requirement for licence holders to prepare an annual summary report on request. Instead, the Minister would have discretionary authority to request issue-related reports if a specific safety concern arises, rather than requiring routine reporting on a fixed schedule.
3. Labelling flexibility. The proposed amendments would eliminate the mandatory use of the Product Facts Table, though medicinal ingredients, recommended use, warnings, and directions for use would still need to be prominently displayed on the label under specified formatting standards. The proposal also revises which post-market changes require a notification versus an amendment, and would allow certain medicinal ingredient information to be provided through a digital label or leaflet when accompanied by a physical label.
4. Reduced administrative notifications. The number of GMP notifications required for building, equipment, or procedural changes would be decreased, and site licence renewals would shift from a fixed schedule to a risk-based system.

What the Survey Is Asking Companies to Quantify 

Rather than general commentary, the questionnaire asks for specific cost data: what it currently costs to prepare a Class I product licence application compared to registering under a monograph, potential sales gained from products reaching market up to 60 days sooner under registration, the cost difference between submitting a notification and an amendment for the same type of change, the cost to renew a site licence, and the cost of retaining vigilance records under different formats. Health Canada is also asking associations to report on membership size, the proportion of members that meet the small business definition (fewer than 100 employees or under $5 million in annual gross revenue), and geographic distribution. 

Where This Fits in the Regulatory Process 

This survey builds on Health Canada’s September 2025 report on red tape reduction and was added to the department’s Forward Regulatory Plan in December 2025. The information collected through the cost-benefit analysis will be used to prepare the Regulatory Impact Analysis Statement that accompanies the draft regulations. Those draft regulations are expected to be pre-published in the Canada Gazette, Part I, in fall 2026 or winter 2027, followed by a public consultation period. Final publication of the regulations in the Canada Gazette, Part II, is targeted for 2028.

Background on how Health Canada currently regulates this product category is available on its natural health products and non-prescription drugs page. 

What This Means for Your Business 

Companies currently holding NHP product licences have an opportunity to influence how these proposed amendments are evaluated before they are implemented. Businesses that can provide detailed information on their costs associated with licensing, notifications, site licence renewals and record keeping will contribute directly to Health Canada’s assessment with concrete data on the regulatory and economic impacts of the proposals before finalizing the proposal.

This is also a useful point to review internal cost tracking for licensing and post-market activities, since the same information gathered for this consultation will likely be relevant again during the Canada Gazette, Part I comment period.