Notice – Release of ICH M9: Biopharmaceutics Classification System (BCS) Based Biowaivers
August 26, 2020
Our file number: 20-109235-116
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. This guidance has been developed by the appropriate ICH Expert Working Group and has been subject to consultation by the regulatory parties, in accordance with the ICH Process. The ICH Assembly has endorsed the final draft and recommended its implementation by membership of ICH. In implementing the ICH M9 guideline, it replaces the Health Canada guidance document: Biopharmaceutics Classification System Based Biowaiver. It is recommended that the Health Canada BCS Based Biowaiver Evaluation Template be completed for drug submissions that include a biowaiver request.
As per its commitment to ICH as a standing member, Health Canada is implementing this guidance with no modifications. In implementing this ICH guidance, Health Canada endorses the principles and practices described therein. This document should be read in conjunction with this accompanying notice and with the relevant sections of other applicable Health Canada guidances. This and other Guidance documents are available on the ICH Website. Please note that the ICH website is only available in English. If you would like to request a copy of the French version of the document, please contact the HPFB ICH inbox.
Should you have any questions or comments regarding the content of the guidance, please contact:
Health Canada - ICH Coordinator
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