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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....

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)....

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...

Health Canada’s Therapeutic Products Directorate (TPD) and Biologics and Genetic Therapies Directorate (BGTD) are responsible for reviewing the applications for authorization to...

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.

This guidance is intended to harmonize and to update the prescribing information for nonsteroidal anti-inflammatory drugs () indicated for controlling pain and inflammation...

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....

These guidelines have been developed by a Therapeutic Products Programme's Working Group for the Toxicological Assessment of Contraceptive Steroids in close consultation with...

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

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...

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...

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...

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...

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...

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...

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

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...

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...

Adoption of International Conference on Harmonisation of Technical Requirements for the Registration of Pharmaceuticals for Human Use (ICH) Guidance Document: Q6A:...

The Special Access Programme (SAP) allows practitioners to request access to drugs that are unavailable for sale in Canada. This access is limited to patients with serious or...