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19

Oct 2026

What Happens When an NHP Batch Fails Quality Testing?
What Happens When an NHP Batch Fails Quality Testing?
By
At a Glance When a Natural Health Product (NHP) batch fails quality testing, manufacturers and importers must investigate the result, assess its potential impact on product safety and quality, and […] Read More >>

19

Oct 2026

What Does a Quality Assurance Person Do for Natural Health Products?
What Does a Quality Assurance Person Do for Natural Health Products?
By
At a Glance A Quality Assurance Person (QAP) is responsible for ensuring that Natural Health Products (NHPs) meet applicable quality requirements before they are made available for sale in Canada. […] Read More >>

19

Oct 2026

Can You Import NHPs into Canada Without Your Own Site Licence?
Can You Import NHPs into Canada Without Your Own Site Licence?
By
At a Glance Companies seeking to import Natural Health Products (NHPs) into Canada do not necessarily need to obtain their own Site Licence. Under Canada’s Natural Health Products Regulations, commercial […] Read More >>

16

Oct 2026

Health Canada Announces Interim Compliance Approach for NHP Monograph Labelling Updates
Health Canada Announces Interim Compliance Approach for NHP Monograph Labelling Updates
By
At a Glance Before Bulletin No. 13, Health Canada expected product licence holders to align labels affected by monograph revisions with the latest version of the monograph within three years […] Read More >>

09

Oct 2026

Bringing a Probiotic to Market in Canada: NHP, Food and Novel Food Pathways
Bringing a Probiotic to Market in Canada: NHP, Food and Novel Food Pathways
By
Abstract Bringing a probiotic product to market in Canada begins with determining how the finished product will be classified. Depending on its composition, dosage form, intended use, claims and overall […] Read More >>

08

Sep 2026

510(k) vs De Novo vs PMA: Choosing the Right FDA Medical Device Pathway
510(k) vs De Novo vs PMA: Choosing the Right FDA Medical Device Pathway
By
At a Glance The U.S. Food and Drug Administration (FDA) classifies medical devices into Class I, Class II, or Class III according to the regulatory controls necessary to provide reasonable […] Read More >>

21

Aug 2026

Health Canada Expands the List of Interchangeable Terms for NHP Labelling
Health Canada Expands the List of Interchangeable Terms for NHP Labelling
By
At a Glance Health Canada’s Natural and Non-prescription Health Products Directorate (NNHPD) has updated its List of Interchangeable Terms to provide greater flexibility when labelling Natural Health Products (NHPs) and […] Read More >>

19

Aug 2026

Clinical Supply Chain Oversight for Live Biotherapeutic Trials: Protecting Product Viability from Manufacturing to Patient
Clinical Supply Chain Oversight for Live Biotherapeutic Trials: Protecting Product Viability from Manufacturing to Patient
By
At a Glance Live Biotherapeutic Products (LBPs) are transforming therapeutic development, with clinical programs expanding across gastrointestinal disorders, metabolic disorders, immunology, oncology, and rare conditions. Unlike conventional pharmaceutical Read More >>

14

Aug 2026

Postbiotics vs. Probiotics: Regulatory and Clinical Differences
Postbiotics vs. Probiotics: Regulatory and Clinical Differences
By
Abstract Probiotics and postbiotics are both increasingly used in microbiome-focused health products, but the regulatory and clinical considerations surrounding them can differ substantially. Probiotics depend on live microorganisms, making strain [&hellip Read More >>

14

Aug 2026

Health Canada Publishes New Guidance for Non-Prescription Drug Market Authorization in Canada
Health Canada Publishes New Guidance for Non-Prescription Drug Market Authorization in Canada
By
At a Glance Health Canada has released a new guidance document, How to apply for market authorization for a non-prescription drug in Canada, providing industry with its first comprehensive roadmap […] Read More >>

06

Aug 2026

Adverse Event Monitoring in Probiotic Clinical Trials: What Sponsors Need to Get Right
Adverse Event Monitoring in Probiotic Clinical Trials: What Sponsors Need to Get Right
By
At a Glance While many commercially available probiotics have a well-documented history of safe use in healthy populations, clinical trials evaluating live biotherapeutic products (LBPs) or probiotic dietary supplements are […] Read More >>

31

Jul 2026

Cosmetic Claims in Canada: What Cosmetic Companies Can (and Can’t) Say
Cosmetic Claims in Canada: What Cosmetic Companies Can (and Can’t) Say
By
At a Glance Marketing claims are one of the most important factors determining how a cosmetic product is regulated in Canada. While cosmetics may claim to cleanse, beautify, moisturize, or […] Read More >>

31

Jul 2026

IND Requirements for Live Biotherapeutic Products: What Sponsors Need to Know
IND Requirements for Live Biotherapeutic Products: What Sponsors Need to Know
By
Abstract Live Biotherapeutic Products (LBPs) are biological products that contain live organisms, are applicable to the prevention, treatment, or cure of a human disease or condition, and are not vaccines. […] Read More >>

15

Jul 2026

Synbiotics: Regulatory Classification and Clinical Trial Considerations
Synbiotics: Regulatory Classification and Clinical Trial Considerations
By
Abstract Synbiotics represent an increasingly sophisticated approach to microbiome-focused products by combining live microorganisms with substrates designed to support beneficial microbial activity. However, regulatory classification and evidence requirem Read More >>

15

Jul 2026

Postbiotics: The “Non-Live” Microbe Trend Reshaping Functional Health Products
Postbiotics: The “Non-Live” Microbe Trend Reshaping Functional Health Products
By
Abstract Postbiotics are emerging as a significant new category of microbiome-focused products, offering potential advantages over traditional probiotics through improved stability, simplified manufacturing, and greater formulation flexibility. However, de 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 >>

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