Many companies entering the Canadian market ask the same question: does my product require an NPN? The answer depends on scope. In Canada, a product may require a Natural Product […] Read More >>
Health Canada has released an updated version of the Natural Health Products Management of Applications Policy (NHP MAP), replacing the previous guidance published in April 2019. The revised NHP MAP […] Read More >>
The Canadian Food Inspection Agency (CFIA) has announced important updates to the Safe Food for Canadians (SFC) licensing process, introducing additional information requirements, enhanced pre-issuance review procedures, and significantly longer […] Read More >>
Health Canada is abolishing Foreign Site Reference Numbers (FSRNs). The details are outlined below, but the key takeaway is this: FSRNs are no longer available or accepted, and foreign site […] Read More >>
Health Canada’s Natural and Non-prescription Health Products Directorate (NNHPD) has launched a 15-business-day consultation on a new draft Prebiotics Monograph for Natural Health Products (NHPs). Stakeholders have until February 20, […] Read More >>
On November 18, 2025, the Natural and Non-prescription Health Products Directorate (NNHPD) introduced two important regulatory tools designed to bring greater clarity, predictability, and flexibility to Canada’s Natural Health Product […] Read More >>
Health Canada has confirmed that implementation of the proposed cost recovery fees for Natural Health Products (NHPs) will not proceed on December 1, 2025, as originally planned. According to correspondence […] Read More >>
In October 2024, Health Canada launched a consultation to update the 2015 Good Manufacturing Practices (GMP) Guidance Document (Version 3.0). That draft focused on simplifying language, aligning with international quality […] Read More >>
dicentra published a new JALM article (Aug 2025) presenting a staged framework that integrates analytical validity, clinical validity, clinical utility, regulatory strategy, and integrated evidence generation. Regulatory Approved Point-of-Care Diagnostics Read More >>
If you plan to sell cosmetics in Canada, one of the first compliance steps is completing Health Canada’s Cosmetic Notification Form (CNF). This form is an essential regulatory requirement under […] Read More >>
As Canada continues to engage in an ongoing global trade war, it is important that you ensure your products are properly classified, both from a regulatory and a commercial perspective. […] Read More >>
As Canadian businesses prepare to celebrate Canada Day, many are looking to highlight their national pride by adding “Made in Canada” or “Product of Canada” claims to their product labels. […] Read More >>
Health Canada has launched a consultation on a proposed regulatory pathway for health products containing cannabidiol (CBD) that would allow access without a prescription. This marks a significant step in […] Read More >>
Originally published March 10, 2025. Updated June 18, 2025, to reflect Health Canada’s June 9 expansion of the workload prioritization approach to include Class II submissions. Health Canada’s Natural and […] Read More >>
Originally published March 4, 2025. Updated April 1, 2025, to reflect the March 26 announcement from Health Canada. Health Canada has now published the anticipated Ministerial Order confirming a temporary […] Read More >>
Those familiar with the Site Licensing renewal process know that SL renewals must be filed 30 days before the expiry date of the licence. Failure to meet the deadline will […] Read More >>
Health Canada has released Batch 4b for consultation, marking another significant step in its Natural Health Products (NHP) monograph revision process. This ongoing initiative by the Natural and Non-Prescription Health […] Read More >>
Health Canada has opened a consultation to update its 2015 Good Manufacturing Practices (GMP) guide for Natural Health Products (NHPs). This effort is aimed at refining the existing guidelines, making […] Read More >>
Ashwagandha root extract is a well-known adaptogen, recognized for its potential to reduce stress, improve energy levels, and support overall well-being. While it is widely used in the Natural Health […] Read More >>
Health Canada has recently launched a significant update to streamline the submission process for medical devices. The Medical Devices Directorate (MDD) is now offering the Regulatory Enrolment Process (REP) as […] Read More >>