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09

Jul 2026

Health Canada Red Tape Reduction Initiative: NHP Survey
Health Canada Red Tape Reduction Initiative: NHP Survey
By
Abstract Introduction Health Canada’s Red Tape Reduction Initiative for Natural Health Products represents the latest step in the modernization of Canada’s NHP regulatory framework. The proposed amendments are intended to […] Read More >>

26

Jun 2026

AI Hallucinations: Why Regulators Are Paying Attention
AI Hallucinations: Why Regulators Are Paying Attention
By
Regulatory and oversight concern around AI hallucinations is not centered only on intentional misuse, but on the introduction of unverifiable, unsupported, or fabricated information into regulated workflows. As organizations increasingly […] Read More >>

26

Jun 2026

FDA QMSR Requirements in 2026: What Medical Device Manufacturers Need to Know
FDA QMSR Requirements in 2026: What Medical Device Manufacturers Need to Know
By
On February 2, 2026, the FDA’s revised Quality Management System Regulation (QMSR) officially became effective, replacing the long-standing Quality System (QS) Regulation framework under 21 CFR Part 820. While the […] Read More >>

26

Jun 2026

Health Canada Finalizes Phase 2 MDEL Modernization: What Importers Need to Know
Health Canada Finalizes Phase 2 MDEL Modernization: What Importers Need to Know
By
Health Canada has finalized the second phase of its modernization of the Medical Device Establishment Licence (MDEL) framework, publishing amendments to the Medical Devices Regulations in the Canada Gazette, Part […] Read More >>

17

Jun 2026

Health Canada Removes FPS Submission Requirement for NHP Applications
Health Canada Removes FPS Submission Requirement for NHP Applications
By
Health Canada has released Natural Health Product Licensing Bulletin No.11 introducing a significant operational change to the way Finished Product Specifications (FPS) are handled for Natural Health Product (NHP) product […] Read More >>

12

Jun 2026

AI-Enabled Medical Devices: Regulatory Expectations Across the Product Lifecycle
AI-Enabled Medical Devices: Regulatory Expectations Across the Product Lifecycle
By
Artificial intelligence is changing the way regulators evaluate medical devices, particularly where software functionality influences clinical decision-making or adapts over time. While software regulation is not new, machine learning introduces […] Read More >>

11

May 2026

Natural Health Products Labelling Compliance Extension: What Industry Needs to Know
Natural Health Products Labelling Compliance Extension: What Industry Needs to Know
By
Health Canada has announced a significant update regarding the implementation timeline for the 2022 amendments to the Natural Health Products Regulations (NHPR) labelling requirements. Under the latest Natural Health Product […] Read More >>

28

Apr 2026

Prebiotic vs Probiotic Claims: Regulatory Considerations
Prebiotic vs Probiotic Claims: Regulatory Considerations
By
As the gut microbiome continues to gain attention across food, natural health products (NHPs), and dietary supplements, prebiotic and probiotic claims have become a central focus for product development and […] Read More >>

24

Apr 2026

Health Canada Reclassifies Sports Electrolyte Products as Foods: What Industry Needs to Know
Health Canada Reclassifies Sports Electrolyte Products as Foods: What Industry Needs to Know
By
Health Canada has announced a significant regulatory update affecting sports electrolyte products, formally transitioning them from the Natural Health Product (NHP) framework to the food regulatory framework. This change reflects […] Read More >>

20

Apr 2026

How AI is Regulated Across FDA, Health Canada, and the EU
How AI is Regulated Across FDA, Health Canada, and the EU
By
AI is already part of your regulatory process AI isn’t coming to life sciences—it’s already here. It’s being used to screen ingredients, draft labels, monitor claims, summarize safety data, assemble […] Read More >>

27

Mar 2026

Does My Product Need an NPN in Canada
Does My Product Need an NPN in Canada
By
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 >>

18

Mar 2026

Health Canada Updates the NHP MAP: What Industry Needs to Know
Health Canada Updates the NHP MAP: What Industry Needs to Know
By
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 >>

12

Mar 2026

Updates to the Safe Food for Canadians (SFC) Licensing Process: What Industry Needs to Know
Updates to the Safe Food for Canadians (SFC) Licensing Process: What Industry Needs to Know
By
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 >>

25

Feb 2026

Health Canada Is Abolishing Foreign Site Reference Numbers: What NHP Companies Need to Know
Health Canada Is Abolishing Foreign Site Reference Numbers: What NHP Companies Need to Know
By
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 >>

06

Feb 2026

Health Canada Consultation: Draft Prebiotics Monograph for Natural Health Products
Health Canada Consultation: Draft Prebiotics Monograph for Natural Health Products
By
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 >>

21

Nov 2025

Health Canada Releases Two New Regulatory Tools: What NHP Companies Need to Know
Health Canada Releases Two New Regulatory Tools: What NHP Companies Need to Know
By
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 >>

31

Oct 2025

Health Canada Postpones Implementation of NHP Cost Recovery Fees
Health Canada Postpones Implementation of NHP Cost Recovery Fees
By
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 >>

05

Sep 2025

Health Canada Finalizes New Good Manufacturing Practices (GMP) Guide for Natural Health Products (NHPs)
Health Canada Finalizes New Good Manufacturing Practices (GMP) Guide for Natural Health Products (NHPs)
By
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 >>

27

Aug 2025

Integrated framework for point-of-care diagnostic validation
Integrated framework for point-of-care diagnostic validation
By
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 >>

25

Aug 2025

Understanding Health Canada’s Cosmetic Notification Form: What You Need to Know
Understanding Health Canada’s Cosmetic Notification Form: What You Need to Know
By
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 >>

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