Health Canada

Briefing packages prepared for the purpose of enabling a new Minister or Deputy Minister to assume their new responsibilities, Overview of the Health Portfolio and its five organizations, Covid overview, First 100 days, Pocket book with Health Portfolio highlights,

COVID-19 vaccines must be manufactured under good manufacturing practices (GMP) conditions. These conditions must be in line with international requirements, which are outlined in the International Council for Harmonization Q7A guideline and applicable Health Canada guidance.

Decisions made about COVID-19 vaccines will follow processes established for reviews under the modified requirements for COVID-19 drugs. Health Canada will start rolling reviews to build towards a complete dossier for each vaccine. The dossier will include data to support the safety, efficacy and...

This document will help manufacturers prepare a submission for a notice of compliance for a COVID-19 drug under the Regulations. It also outlines the process for meeting the post-market regulatory requirements.

The Governor in Council introduced amendments to the Regulations to provide a mechanism for COVID-19 drugs to be authorized through the issuance of an NOC, based on modified requirements that have been transferred from the ISAD IO.

Division 1A of Part C of the Regulations applies to COVID-19 drugs. A person must hold a drug establishment licence (DEL) authorizing any activities conducted with respect to COVID-19 drugs.

The only amendment related to post-market regulation is the Minister’s new (continued) authority to impose terms and conditions for a designated COVID-19 drug (C.01.014.21).

A promising COVID-19 drug may be imported into Canada before it receives a Canadian market authorization. This early importation and placement in Canadian facilities is referred to as “pre-positioning.” It facilitates the immediate distribution of the drug upon authorization, making it available...

As a consequence of the review, authorization and oversight of COVID-19 drugs under the Regulations, manufacturers may benefit from intellectual property protections that are available in respect of a submission that results in an NOC.

The Interim Order (IO) expedites the authorization of Class I to IV medical devices used for COVID-19: sets out the safety, effectiveness and quality requirements for filtering facepiece respirators (FFRs), and provides criteria for Canadian manufacturers developing respirators in Canada.

Information about filtering facepiece respirators and their certification and testing process.

All Canadian-manufactured respirators must meet the minimum performance testing requirements.

For an IO submission, Health Canada requires a report on the results of the performance testing requirements that apply to the product class. Any deviations should be identified and explained.

Due to the urgent public health needs relating to COVID-19, we can issue a market authorization with conditions. This is done to support early access to promising health products when the potential benefits outweigh the potential risks.

At the time of authorization, no major safety concerns have been reported in the available data submitted to Health Canada. We are carefully monitoring the post-market (after authorization) safety and effectiveness of authorized COVID-19 vaccines. As part of our commitment to keep Canadians...

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,...