At a Glance On October 27, 2026, Health Canada published its final Guidance for Clinical Trials with Decentralized Elements, providing regulatory direction for sponsors, investigators, and Contract Research Organizations (CROs) […] Read More >>
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 >>
Abstract Hazard Analysis and Critical Control Point (HACCP) is a preventive food safety system designed to identify biological, chemical and physical hazards and establish controls at points where those hazards […] 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 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 >>
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 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 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 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 >>
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 >>
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