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 >>
For over 25 years, dicentra has been a trusted global leader in regulatory consulting and clinical research for the life sciences and dietary supplement industries. We partner with innovators worldwide […] Read More >>
For over 25 years, dicentra has been a trusted global leader in regulatory consulting and clinical research for the life sciences and dietary supplement industries. We partner with innovators worldwide […] Read More >>
For over 25 years, dicentra has been a trusted global leader in regulatory consulting and clinical research for the life sciences and health product industries. We partner with innovators worldwide […] Read More >>
Abstract Structure/function claims are statements that describe how a dietary supplement or one of its ingredients affects the normal structure or function of the human body. These claims allow manufacturers […] Read More >>
Abstract On October 19, 2026, the U.S. Food and Drug Administration (FDA) announced the availability of its final guidance, New Dietary Ingredient (NDI) Notifications and Related Issues; Identity and Safety […] 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 >>
For over 25 years, dicentra has been a trusted global leader in regulatory consulting and clinical research for the life sciences and dietary supplement industries. We partner with innovators worldwide […] Read More >>
Abstract FDA’s proposed mandatory Generally Recognized as Safe (GRAS) notification rule would create both transitional and recurring costs for companies relying on the GRAS pathway. In its Preliminary Regulatory Impact […] 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 >>
Abstract The Modernization of Cosmetics Regulation Act of 2022 (MoCRA) represented the most significant expansion of the U.S. Food and Drug Administration’s authority over cosmetics since the Federal Food, Drug, […] Read More >>
Abstract L-theanine has become one of the most widely used functional ingredients in beverages formulated to support focus, relaxation, and cognitive wellness. As manufacturers continue to expand into ready-to-drink (RTD) […] Read More >>
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 >>
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 >>
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