Health Canada’s Drug vs Product Monograph: Key Differences
Two pivotal documents in this regulatory landscape, the Health Canada Drug Monograph and Product Monograph, hold distinct roles and purposes. Keep reading to learn more.
... Read moreFDA Fees Summary for 2025
FDA User Fees for Fiscal Year 2025 (FY2025) The FDA’s user fees for FY2025, which runs from October 1, 2024, to September 30, 2025, apply to various industries, including pharmaceuticals, medical devices, biologics, and animal drugs. These fees help support the FDA’s regulatory and review processes, promoting efficient approval and compliance. 1. Prescription Drug User
... Read moreNew Modification to Buffer Zone Affects Food Manufacturers and Suppliers
Simplified Explanation of Changes to Labeling Rules Starting July 2022, food manufacturers and suppliers have been required to display special labeling symbols on certain food products. These include a front-of-package (FOP) nutrition symbol for products high in saturated fat, sugar, or sodium, and a supplemented food caution identifier (SFCI) for supplemented foods with specific health
... Read moreQuality Smart Solutions Launches GRAS Experts to Protect Against Food Safety Risks
GRAS Experts, a new division aimed at tackling ingredient safety concerns and helping businesses stay ahead of regulatory changes and avoiding recalls In light of McDonald’s recent recall of Quarter Pounders due to E. coli contamination, the need for stringent oversight on food ingredients has never been more critical. Quality Smart Solutions has launched GRAS
... Read moreGovernment of Canada Launches Consultation on Plant-Based Egg Alternative Labelling: What Businesses Need to Know
The Canadian Food Inspection Agency (CFIA) has launched a 90-day consultation on proposed guidance for labelling plant-based alternatives to egg products, a critical development for businesses involved in Novel Food Products and ingredients. As the plant-based food market skyrockets, this new consultation presents both an opportunity and a challenge for companies to ensure their products
... Read moreNew Hydration Product Monographs Launched
The NNHPD Opens Consultation on Batch 4 Through new guidelines, stakeholders are invited to shape the future of homeopathic and topical health products. The Natural and Non-Prescription Health Products Directorate (NNHPD) has made a significant announcement, opening a crucial consultation period for Batch 4 of their latest product monographs, including several that will impact the
... Read more7 Must-Know EFSA Novel Food Regulation Changes for 2025: You Need To Be Ready
Are your novel food products ready for the new European Food Safety Authority (EFSA) regulations? If you’re planning to enter the European market in 2025, significant updates to the EFSA novel food regulatory framework are on the horizon, effective from February 1, 2025. These changes will affect everything from risk assessments to labelling, sustainability, and
... Read moreBreaking News: Health Canada’s New GMP Guide for Natural Health Products – Are You Ready?
Health Canada has just released a draft Good Manufacturing Practices (GMP) guide for natural health products (NHPs), marking a monumental shift in how businesses will manufacture, package, label, and store their products. This guide introduces sweeping changes, the first since 2015, to ensure NHPs sold in Canada meet modern safety and quality standards. With updates
... Read moreUnderstanding the Key Changes to Natural Health Product (NHP) Labeling in Canada
Natural health products (NHPs) are widely used in Canada, ranging from vitamins, minerals, and herbal remedies to probiotics and homeopathic medicines. As these products play a vital role in promoting health and wellness, clear and accurate labeling is essential to ensure consumers can make informed decisions about the products they use. To strengthen consumer safety
... Read more