Health Canada

These guidelines have been developed by a Therapeutic Products Programme's Working Group for the Toxicological Assessment of Contraceptive Steroids in close consultation with several experts in the fields of toxicology, pathology and reproductive physiology.

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...

This guidance is intended to harmonize and to update the prescribing information for nonsteroidal anti-inflammatory drugs () indicated for controlling pain and inflammation associated with rheumatic diseases and other less severe conditions.

Canada's regulatory approach: Drugs for rare diseases are authorized for sale in Canada under the Food and Drugs Act and Part C of the Food and Drug Regulations.

Health Canada’s Therapeutic Products Directorate (TPD) and Biologics and Genetic Therapies Directorate (BGTD) are responsible for reviewing the applications for authorization to sell or import drugs for the purposes of conducting clinical trials in Canada.

Health Canada has authorized certain clinical trials in patients in Canada. Our public Clinical Trials Database is a public listing of specific information relating to these trials. Additional publicly accessible registries that further support finding suitable trials are: ClinicalTrials.gov and...

Anyone can find out if a submission has been accepted for review by Health Canada by searching the submissions under review list. We publish Regulatory Decision Summaries (RDS). These summaries explain the purpose of the submission and the reason(s) for Health Canada’s decision on certain health...

Canada’s health care system is complex and involves the participation of multiple stakeholders, who all have distinct roles in the planning and delivery of healthcare services. Health Canada’s decision-making role in approving a drug for marketing is distinct from the roles of those who make...

Special access programs.

To develop options for the registration and disclosure of clinical trial information of health products in Canada, Health Canada began consulting with Canadians in 2005.

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.

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...

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...

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...

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...

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...

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.