Open Government Portal

Drug and medical device approval overview

The purpose of this policy is to ensure timely access to drug/medical device combination products by establishing a single window approach and more efficient submission processing system, while ensuring that combination products marketed in Canada are safe, effective, and of high quality.

Briefing Package for the hearing before the Standing Committee on Public Accounts on 2023 Report 2, Connectivity in Rural and Remote Areas of the Office of the Auditor General of Canada

This guidance is intended to assist sponsors in the collection and analysis of data for Steroid Nasal products for use in the treatment of allergic rhinitis, in order to meet the safety and effectiveness requirements under Part C, Division 8 of the Food and Drug Regulations.

Depending on its ingredients, a dental plaque-disclosing product can be regulated as a drug under the F&DA either as a pharmaceutical drug subject to the Food and Drug Regulations and requires a Drug Identification Number (DIN), or as a natural health product subject to the Natural Health Products Regulations and require a Natural Product Number (NPN).

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.