Health Canada

E9: Statistical Principles of Clinical Trials. 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 objective of this guidance document is to allow the compilation of a single core clinical study report acceptable to all regulatory authorities of the ICH regions. The regulatory authority specific additions will consist of modules to be considered as appendices, available upon request...

This guidance document is intended to aid manufacturers and regulatory representatives in preparing medical device licence applications for dermal fillers.

In recent years, there has been a dramatic increase in the level of interconnectedness and data exchange between medical devices and their network environments. Increased connectivity in medical devices can: improve access to health care information; facilitate more timely diagnoses and...

As a regulator, Health Canada plays an important role in protecting the health and safety of Canadians. Health Canada is committed to being transparent and open about its activities and to making timely and useful information available about health products and health product submissions. Greater...

This Notice serves to inform sponsors of drug submissions pursuant to Division C.08 of the Food and Drug Regulations (i.e., new drug and abbreviated new drug submissions), of proposed modifications to Health Canada’s comparative bioavailability requirements when multiphasic plasma concentration...

This guidance document clarifies the application of the risk classification rules for IVDDs set out in Part II of Schedule I of the Medical Devices Regulations, and was recently rewritten to include updated examples and to conform to Good Guidance Practices.

The Food Source Contribution Table (FSCT) provides estimates of how much various food groups and subgroups contribute to Canadians’ intakes of energy and selected nutrients using data collected in the 2015 Canadian Community Health Survey (CCHS) - Nutrition. Two different datasets are available....

The 2008-2022 Total Diet Study Food Consumption Tables show the daily consumption of each Total Diet Study (TDS) food composite for various age-sex groups. The source for these consumption data is the 2015 Canadian Community Health Survey-Nutrition Component (2015 CCHS-Nutrition). When paired...

This guidance document addresses the development of contraceptive products, intended for use by women during their reproductive years, which contain sex steroids as active ingredient(s).

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.