At a Glance Natural Health Product (NHP) companies in Canada must maintain appropriate quality assurance oversight, but they are not necessarily required to employ a full-time Quality Assurance Person (QAP). […] Read More >>
At a Glance Class III Natural Health Product (NHP) applications in Canada require a more comprehensive regulatory assessment than Class I or Class II submissions. These applications generally involve products […] Read More >>
At a Glance An FDA Form 483 is issued when an FDA investigator identifies conditions during an inspection that, in their judgment, may violate applicable regulatory requirements. For dietary supplement […] Read More >>
At a Glance Receiving an Information Request Notice (IRN) from Health Canada does not automatically mean that a Natural Health Product (NHP) application has been rejected. An IRN identifies additional […] Read More >>
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 >>
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