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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.