Those familiar with the Site Licensing renewal process know that SL renewals must be filed 30 days before the expiry date of the licence. Failure to meet the deadline will […] Read More >>
Clinical trials are the cornerstone of medical research, providing the evidence needed to assess the safety, efficacy, and optimal use of medical interventions. From drug, food, and natural health product […] Read More >>
A Generally Recognized as Safe (GRAS) or New Dietary Ingredient (NDI) notification is essential for novel food ingredient manufacturers and distributors to ensure that their product is recognized as safe […] Read More >>
Health Canada has released Batch 4b for consultation, marking another significant step in its Natural Health Products (NHP) monograph revision process. This ongoing initiative by the Natural and Non-Prescription Health […] Read More >>
Health Canada has opened a consultation to update its 2015 Good Manufacturing Practices (GMP) guide for Natural Health Products (NHPs). This effort is aimed at refining the existing guidelines, making […] Read More >>
Ashwagandha root extract is a well-known adaptogen, recognized for its potential to reduce stress, improve energy levels, and support overall well-being. While it is widely used in the Natural Health […] Read More >>
Health Canada has recently launched a significant update to streamline the submission process for medical devices. The Medical Devices Directorate (MDD) is now offering the Regulatory Enrolment Process (REP) as […] Read More >>
Cosmetics are currently regulated in Canada through Health Canada’s Cosmetic Regulations (which falls under the Food and Drugs Act). Under Sections 30 and 31 of the Cosmetic Regulations, it is […] Read More >>
Health Canada continues its progress in revising the monographs for natural health products (NHPs), with the release of Batch 4a for consultation. This is part of the ongoing effort by […] Read More >>
A Quality Management System (QMS) is a structured framework that organizations use to ensure their products or services consistently meet customer expectations and regulatory requirements. Its purpose is to ensure […] Read More >>
Achieving Generally Recognized as Safe (GRAS) status is a critical milestone in food and ingredient safety, assuring consumers, regulatory authorities, and industry stakeholders that a product or ingredient is safe […] Read More >>
On July 3, 2024, Health Canada officially permitted the use of Veterinary Health Products (VHPs) via the in-feed route of administration. This significant regulatory update opens new opportunities for maintaining […] Read More >>
On December 28, 2025, a new final rule from the FDA regarding medical gases will take effect. This rule aims to update and clarify the regulations surrounding current good manufacturing […] Read More >>
On April 29, 2024, the U.S. Food and Drug Administration (FDA) announced a final rule amending the regulations for in vitro diagnostics (IVDs) to include laboratory-developed tests (LDTs) explicitly. Effective […] Read More >>
On May 17, 2024, Health Canada published the Interim Order Concerning the Sale of Certain Natural Health Products Containing Ephedrine or Pseudoephedrine. This order introduces specific condition-of-sale regulations for natural […] Read More >>
Health Canada continues its commitment to updating and revising its monographs, releasing Batch 3 for consultation. This represents another crucial step in ensuring the accuracy and applicability of information provided […] Read More >>
On April 24, 2024, Health Canada published amendments to the Cosmetics Regulations in Canada. These amendments, detailed in the Cosmetic Regulations under the Food and Drugs Act, signify important changes […] Read More >>
On May 12, 2023, Health Canada alerted industry of a proposal to introduce cost recovery fees for Natural Health Products (NHPs). This proposal, initially released for consultation from May 12 […] Read More >>
In Canada, infant formulas and human milk fortifiers are regulated under the Food and Drug Regulations, Part B, Division 25 (B.25.019). Health Canada defines infant foods as food to be […] Read More >>
Health Canada’s ongoing efforts to update and revise its monographs continue with the release of Batch 2 for consultation. This marks another significant step in ensuring the accuracy and relevance […] Read More >>
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