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 >>
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 >>
At a Glance Vanessa’s Law, formally known as the Protecting Canadians from Unsafe Drugs Act, strengthened Health Canada’s authority to identify and respond to safety risks associated with therapeutic products […] Read More >>
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 >>
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 >>
At a Glance Stability testing is the process of evaluating how the quality of a dietary supplement or Natural Health Product (NHP) changes over time under defined storage conditions. The […] Read More >>
At a Glance AI literature review tools can help regulatory and scientific teams search, screen, organize, and summarize growing volumes of information. Their greatest value lies in narrow, repetitive tasks […] Read More >>
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 >>
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 >>
At a Glance Health Canada has released a draft Quality of Natural Health Products Guide for consultation, proposing the most significant update to NHP quality guidance since the finalized Good […] Read More >>
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 >>
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 >>
Abstract U.S. GRAS status is an important safety milestone, but it does not authorize an ingredient for sale in Canada. Instead, Health Canada evaluates ingredients under its own regulatory framework, […] Read More >>
Abstract Canada’s Front-of-Package (FOP) nutrition labelling requirements are now fully enforceable. Since January 1, 2026, most prepackaged foods imported, manufactured, or packaged at retail in Canada must display the prescribed […] Read More >>
Abstract Good Manufacturing Practices are fundamental to product quality in both the Canadian Natural Health Product and U.S. dietary supplement industries. However, the requirements are not interchangeable. In the United […] Read More >>
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 >>
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 >>
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 >>
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 >>
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 >>