Notice – Release of ICH M9: Biopharmaceutics Classification System (BCS) Based Biowaivers

Notice – Release of ICH M9: Biopharmaceutics Classification System (BCS) Based Biowaivers Health Canada is pleased to announce the implementation of International Council for Harmonisation of Technical Requirements of Pharmaceuticals for Human Use (ICH) Guidance M9: Biopharmaceutics Classification System (BCS) Based Biowaivers. 2023-10-29 Health Canada open-ouvert@tbs-sct.gc.ca Health and SafetynoticeInternational Council for-HarmonisationICH Technical Requirementsguidance M9ICH M9biopharmaceutics classification systemM9 BCSbased biowaiverspharmaceuticals for human-use Notice – Release of ICH M9: Biopharmaceutics Classification System (BCS) Based BiowaiversHTML https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/applications-submissions/guidance-documents/international-conference-harmonisation/multidisciplinary/notice-ich-m9-biopharmaceutics-classification-system-based-biowaivers.html Notice – Release of ICH M9: Biopharmaceutics Classification System (BCS) Based BiowaiversHTML https://www.canada.ca/fr/sante-canada/services/medicaments-produits-sante/medicaments/demandes-presentations/lignes-directrices/international-conference-harmonisation/multidisciplinaire/avis-ich-m9-dispense-demonstration-bioequivalence-fondee-systeme-classification-biopharmaceutique.html

Health Canada is pleased to announce the implementation of International Council for Harmonisation of Technical Requirements of Pharmaceuticals for Human Use (ICH) Guidance M9: Biopharmaceutics Classification System (BCS) Based Biowaivers.

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