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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...

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.

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...

Several different types of treatments for COVID-19 have been developed. Examples include drugs that reduce or stop the virus from multiplying in human cells and drugs that treat the symptoms of COVID-19.

Due to the COVID-19 pandemic, enhanced border measures authorized by the Quarantine Act were introduced to ensure appropriate actions are taken to reduce the spread of the virus.

Guidance document provides applicants seeking authorization to conduct COVID-19 drug clinical trials specifically around the applications guidelines and process.