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This section of the guidance outlines requirements for the licence holder after authorization of the clinical trials.

This section of the guidance outlines the application processes and guidelines under the Regulations.

This section of the guidance outlines the additional requirements for good clinical practices, qualified investigators, and labelling.

This section of the guidance outlines additional responsibilites around consent of participants and registration.

Guidance for applicants seeking authorization to conduct COVID-19 drug clinical trials.

Many vaccines are being studied to see if they will prevent COVID-19, and Health Canada is prioritizing reviews of all COVID-19 vaccine submissions.

By way of this update, Health Products and Food Branch (HPFB) is reminding sponsors that the mandatory date for use of the Regulatory Enrolment Process (REP) and the Common...

The Clinical Trials for Medical Devices and Drugs Relating to COVID-19 Regulations (Regulations) were published on March 2, 2022. They came into effect on February 27, 2022,...

This document gives information on changes made to the Food and Drug Regulations. It was published on October 14, 2020, in Part II of the Canada Gazette. See Regulations...

Health Canada is aware of the growing interest in the use of psilocybin, including psilocybin that occurs naturally in certain mushroom species, for potential therapeutic...

Health Canada is aware of the growing interest in the use of psilocybin, including psilocybin that occurs naturally in certain mushroom species, for potential therapeutic...

Health Canada is issuing this notice to clinical trial sponsors to clarify the approach to clinical research with psilocybin. Health Canada recognizes that conducting clinical...

The purpose of this Notice of Amendment is to notify that Health Canada has removed tramadol from the Prescription Drug List (PDL) and added it to Schedule I of the Controlled...

The purpose of this Notice of Amendment is to notify that Health Canada has revised the listing of "brimonidine or its salts" on the Prescription Drug List (PDL). Note that both...

The purpose of this Notice of Amendment is to notify that Health Canada has added phytocannabinoids to the Human and Veterinary Prescription Drug Lists (PDL).

The purpose of this Notice of Amendment is to notify that Health Canada will add Epinephrine topical solution for hemostasis when sold at a concentration equal to or greater...

Health Canada is pleased to announce the implementation of International Council for Harmonisation of Technical Requirements of Pharmaceuticals for Human Use (ICH) Guidance...

Health Canada is pleased to announce the implementation of International Council for Harmonisation of Technical Requirements of Pharmaceuticals for Human Use (ICH) Guidance M9:...

This document is intended to clarify how SaMD fits into Health Canada's regulatory framework for medical devices, based on current interpretation of the definitions of “device”...

This document outlines the way in which Health Canada manages applications for medical device licences.