Health Canada

Information on the Moderna COVID-19 vaccine, including how it works, how it's given, possible side effects and vaccine safety after authorization.

As part of the government’s broad response to the pandemic, Health Canada introduced a number of innovative and agile regulatory measures. These measures expedite the regulatory review of COVID-19 health products without compromising safety, efficacy and quality standards. These measures are...

The guidance document concerning amendments to the Food and Drug Regulations for drugs for use in relation to COVID-19 indicates that the plain language labelling requirements for mock-up labels and a brand name assessment package do not apply (C.08.002(2)(j.1) and C.08.002(2)(o)). Although not...

Variant strains of SARS-CoV-2 are emerging that may affect the level of protection provided by currently authorized COVID-19 vaccines. As a result, manufacturers are adapting authorized COVID-19 vaccines to provide protection against infection and disease caused by virus variants.

Modified requirements for COVID-19 drugs allow for the filing of rolling submissions (section C.08.002(2.3) of Canada's Food and Drug Regulations). Before filing a submission for a rolling review, sponsors of clinical trials are expected to have gathered a certain level of evidence on the safety,...

This document provides guidance on developing the evidence and documentation needed to obtain an authorization and licensing for importing or selling a COVID-19 vaccine in Canada.

Coronavirus, COVID-19, pandemic, outbreak, testing, diagnosis, contact tracing, testing devices, point-of-care, POC, antigen, antibodies, molecular, FDA, non-laboratory use

the Minister of Health signed the Interim Order No. 2 Respecting Drugs, Medical Devices and Foods for a Special Dietary Purpose in Relation to COVID-19. An IO is one of the fastest mechanisms available to address large-scale public health emergencies, without following the usual regulatory...

The tables below list the COVID-19-related clinical trials which have been authorized by Health Canada through the Food and Drug Regulations or the Interim order No. 2 for clinical trials for medical devices and drugs related to COVID-19.

the Minister of Health signed the Interim Order No. 2 Respecting Drugs, Medical Devices and Foods for a Special Dietary Purpose in Relation to COVID-19. IO No. 2 extends and modifies certain measures for drugs that were in the first interim order. An IO is one of the fastest mechanisms available...

How Health Canada is addressing clinical trials of drugs and vaccines, its expedited review process and the Special Access Program to find therapies to prevent or treat COVID-19.

The purpose of this notice is to advise stakeholders that Health Canada is proposing to: maintain the flexibilities and regulatory oversight provided by the Interim order respecting clinical trials for medical devices and drugs relating to COVID-19 until at least the fall of 2021, and bring...

Two of the vaccines approved for use in Canada are messenger RNA vaccines (called mRNA vaccines): Pfizer and Moderna. mRNA vaccines are a new type of vaccine. They don't use live virus to trigger an immune response.

Two of the vaccines approved for use in Canada are viral vector-based vaccines: AstraZeneca and Janssen. These types of vaccines use a harmless virus (in this case, the adenovirus) as a delivery system. This vector virus is not the virus that causes COVID-19. You can't get COVID-19 from the...

The list below includes all applications received by Health Canada for drugs and vaccines used for the COVID-19 pandemic. This list includes applications received under the interim order and those received under the Food and Drug Regulations. The current status of each application is also noted.

Drugs and vaccines that have been authorized by Health Canada for use in relation to the COVID-19 pandemic are listed here.

The medicine regulators from Australia, Canada, Singapore, Switzerland and the United Kingdom (Access Consortium) have discussed the regulatory evidence requirements for COVID-19 vaccine approvals and considerations for post-market pharmacovigilance. This collective statement on COVID-19 vaccines...

This Points to Consider document lays out a regulatory approach for updating authorised coronavirus vaccines should mutations at any time make them less efficacious due to insufficient cross-reactivity.

Learn about food safety during the coronavirus disease (COVID-19) pandemic and how to keep you and your family safe.

The Government of Canada is working to respond to challenges raised by the food industry as a result of the COVID-19 pandemic while continuing to ensure that Canadians have access to safe and nutritious food.