On July 20th, 2026, Health Canada opened up a consultation period for a newly revised guidance document describing the quality requirements for Natural Health Products in Canada. Health Canada’s guidance documents have always been an important resource for applicants, who must demonstrate that their product meets Health Canada’s requirements for safety, efficacy and quality before it can be marketed. Any Canadian manufacturers or importers need to be aware of the requirements and keep their records and products up-to-date with these quality standards.
Health Canada’s 2026 draft Quality of Natural Health Products Guide provides updated guidance reflecting current quality expectations and is intended to make their review process clearer and more flexible. The draft addresses areas including corrective actions and performance, identity, quantity, potency, purity and stability.
Importantly, the draft is currently under consultation, with feedback open from July 20 to September 20, 2026. Health Canada expects to publish a final version later in 2026, followed by an appropriate transition and implementation period. Any comments to Health Canada can be submitted through email, and any information about this can be seen in the following link: Consultation: Draft revised Quality of natural health products guide – Canada.ca
Whenever Health Canada publishes proposals or drafts and opens them up for consultation, it is a perfect opportunity to give feedback through your industry insight and knowledge. The insight given by industry players and subject matter experts is valuable to take into account when establishing these requirements, given that Health Canada’s Natural Health Product guidance documents play a vital role in Good Manufacturing Practices and establishing the Canadian requirements for analytical testing and product release, especially when importing NHPs into Canada.
Quality assurance professionals can add significant value by evaluating whether the product’s formulation, raw materials, manufacturing process, testing program and quality documentation tell a consistent regulatory story. A practical quality review should consider whether the finished product can be appropriately identified and quantified, whether purity requirements address relevant risks, whether potency is controlled where applicable, and whether stability supports the proposed shelf life. Manufacturing and testing activities should also be aligned with applicable good manufacturing practices.
For all industry members, whether you are a license holder or are interested in working with NHPs in Canada, the draft guide is an opportunity to review their quality systems according to Health Canada’s guidance. Having your quality team review these changes and requirements will give your team members more direction when reaching out to Health Canada with your comments on these changes.
Blog Author
Matthew Lai
Matthew holds a B.Sc. in Honours Biology from the University of Waterloo and a Certificate in Regulatory Affairs from Humber College, where he developed a strong interest in Quality Assurance and the regulatory standards for medical devices, drugs, and natural health products. With nearly 4 years of experience, Matthew has been working closely with clients interested in manufacturing or importing Natural Health Products.
