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Health Canada is pleased to announce the adoption of the ICH guidance E16: Biomarkers Related to Drug or Biotechnology Product Development: Context, Structure and Format of Qualification Submissions. 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 Access to Information Act (the Act) gives Canadian citizens, permanent residents and all individuals and corporations present in Canada the right of access to records under the control of a government institution subject to the Act. The Act complements, but does not replace, other means of obtaining government information. This report has been prepared and tabled in Parliament in accordance with section 72 of the Act. It covers the period from April 1, 2022, to March 31, 2023, for the Impact Assessment Agency of Canada (IAAC). The annual report is intended to ensure accountability for the actions and decisions …

Given the fast pace of innovation in digital health technologies specifically in relation to medical devices, Health Canada is undertaking an initiative to adapt its approach to support better access to therapeutic products based on healthcare system needs.

Health Canada has implemented the International Council for Harmonisation of Technical Requirements of Pharmaceuticals for Human Use (ICH) Guidance: E2D Post-Approval Safety Data Management: Definitions and Standards for Expedited Reporting via our Guidance Document for Industry - Reporting Adverse Reactions to Marketed Health Products, which took effect on March 3, 2011.

Health Canada is initiating the transition from its current medical device categorization method to the Global Medical Device Nomenclature (GMDN), in order to improve the availability, access to, and the quality of information available on medical devices in Canada. Continuous and significant technological advancement in the field of medical devices makes it necessary for Health Canada to implement a nomenclature designed to keep pace with medical devices innovations.

Each year CCOHS prepares an Annual Report (of the Council) detailing its goals and accomplishments for the year. This report also includes the audited CCOHS Financial Statements.

In agreeing to apply the Canada-European Union Comprehensive Economic and Trade Agreement (CETA), Canada has committed to provide up to two years of sui generis (of its own kind) protection for new pharmaceutical products protected by an eligible patent, from the expiry of the patent. Canada has implemented this commitment by introducing Certificates of Supplementary Protection (CSPs) for medicinal ingredients, applicable for Canadian pharmaceuticals, biologics and veterinary drugs.

This guidance was developed by the appropriate ICH Expert Working Group and was subject to consultation by the regulatory parties, in accordance with the ICH Process. ICH E10 has been implemented by the regulatory bodies of the United States, European Union, Japan, Switzerland and Australia.

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 Steering Committee has endorsed the final draft and recommended its adoption by the regulatory bodies of the European Union, Japan and USA.

The purpose of this guidance document is to provide manufacturers of Class IV Human Immunodeficiency Virus (HIV) rapid diagnostic tests (RDTs) intended to be used at the point of care (POC) and/or for self-testing (home testing) with specific recommendations on: (1) the analytical and clinical data, and (2) device labelling, required to support a medical device licence application.