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 >>
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 >>
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 >>
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 >>
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 >>
Abstract Good Manufacturing Practices (GMPs) establish the controls necessary to help ensure Natural Health Products (NHPs) are consistently manufactured, packaged, labelled, imported, distributed and stored in a manner that supports […] Read More >>
At a Glance A GRAS dossier is often viewed as a regulatory submission prepared solely to support commercialization in the United States. In reality, a well-developed GRAS dossier can become […] Read More >>
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 >>