In October 2024, Health Canada launched a consultation to update the 2015 Good Manufacturing Practices (GMP) Guidance Document (Version 3.0). That draft focused on simplifying language, aligning with international quality […] The post Health Canada Finalizes New Good Manufacturing Practices (GMP) Guide for Natural Health Products (NHPs) appeared first on dicentra.| dicentra
Discover dicentra’s integrated framework for validating point-of-care (POC) diagnostics, from lab to clinic to regulatory approval.| dicentra
If you plan to sell cosmetics in Canada, one of the first compliance steps is completing Health Canada’s Cosmetic Notification Form (CNF). This form is an essential regulatory requirement under […] The post Understanding Health Canada’s Cosmetic Notification Form: What You Need to Know appeared first on dicentra.| dicentra
FDA has banned Red 3 for foods & ingestible drugs. Learn the impact, compliance dates, and petition steps for ingredient companies.| dicentra
Misusing HS-Codes can lead to delays, tariffs, or penalties. Learn how to classify foods, NHPs, and drugs correctly for import into Canada.| dicentra
Learn the rules for using “Made in Canada” or “Product of Canada” on your labels. Stay compliant with CFIA and Competition Bureau guidance.| dicentra
FDA tools Elsa and CDRH-GPT mark a shift in oversight. Learn how AI could impact GRAS, NDI, and device reviews and how to be submission-ready| dicentra
Explore the differences between Risk-Based Monitoring (RBM) and 100% Source Data Verification (SDV) for clinical trials| dicentra
Learn what a Clinical Research Feasibility Assessment (CRFA) is and how it helps sponsors plan, evaluate, and de-risk clinical trials.| dicentra
Is eliminating self-affirmed GRAS the answer? Kennedy thinks so—dicentra explores what this means for FDA oversight and food safety.| dicentra