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Depending on its ingredients, a dental plaque-disclosing product can be regulated as a drug under the F&DA either as a …
Health Canada is pleased to announce the adoption of the ICH guidance E16: Biomarkers Related to Drug or Biotechnology Product …
Given the fast pace of innovation in digital health technologies specifically in relation to medical devices, Health Canada is undertaking …
Health Canada has implemented the International Council for Harmonisation of Technical Requirements of Pharmaceuticals for Human Use (ICH) Guidance: E2D …
Health Canada is initiating the transition from its current medical device categorization method to the Global Medical Device Nomenclature (GMDN), …
In agreeing to apply the Canada-European Union Comprehensive Economic and Trade Agreement (CETA), Canada has committed to provide up to …
This guidance was developed by the appropriate ICH Expert Working Group and was subject to consultation by the regulatory parties, …
This guidance has been developed by the appropriate ICH Expert Working Group and has been subject to consultation by the …
The purpose of this guidance document is to provide manufacturers of Class IV Human Immunodeficiency Virus (HIV) rapid diagnostic tests …
This document is intended to provide guidance for registration applications on the content and qualification of impurities in new drug …