Guidance for market authorization requirements for COVID-19 vaccines: Review process, communications and transparency

Guidance for market authorization requirements for COVID-19 vaccines: Review process, communications and transparency 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 quality of the proposed vaccine. 2021-07-29 Health Canada open-ouvert@tbs-sct.gc.ca Health and SafetycoronavirusCOVID-19pandemicdrugsmedicationsvaccinesmarket authorizationlicensingimporting or sellingCOVID-19 vaccinereview processtransparency Guidance for market authorization requirements for COVID-19 vaccines: Review process, communications and transparencyHTML https://www.canada.ca/en/health-canada/services/drugs-health-products/covid19-industry/drugs-vaccines-treatments/guidance-market-authorization-vaccines/review-process-communications-transparency.html Guidance for market authorization requirements for COVID-19 vaccines: Review process, communications and transparencyHTML https://www.canada.ca/fr/sante-canada/services/medicaments-produits-sante/covid19-industrie/medicaments-vaccins-traitements/ligne-directrices-autorisations-mise-marche-vaccins/processus-examen-communications-transparence.html

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 quality of the proposed vaccine.

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