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.

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Dernière modification avril 17, 2026, 17:23 (TU)
Créé le avril 17, 2026, 17:23 (TU)
criticality_level []
geographic_scope []
open_canada_collection publication
open_canada_date_published 2020-08-26 00:00:00
open_canada_keywords {"fr": ["avis", "Conseil international pour l'harmonisation", "exigences techniques ICH", "lignes directrices M9", "ICH M9", "système de classification biopharmaceutique", "M9 BCS", "dispenses biologiques basées", "produits pharmaceutiques à usage humain"], "en": ["notice", "International Council for-Harmonisation", "ICH Technical Requirements", "guidance M9", "ICH M9", "biopharmaceutics classification system", "M9 BCS", "based biowaivers", "pharmaceuticals for human-use"]}
open_canada_subject ["health_and_safety"]
sensitivity_level unrestricted
title_fr Avis – Publication de l’ICH M9: Dispense de démonstration de bioéquivalence fondée sur le système de classification biopharmaceutique
update_frequency as_needed