Guidance for market authorization requirements for COVID-19 vaccines: Rolling submissions, non-clinical and clinical requirements

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, quality and efficacy of their vaccine.

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Champ Valeur
Dernière modification avril 17, 2026, 22:02 (TU)
Créé le avril 17, 2026, 22:02 (TU)
criticality_level []
geographic_scope []
open_canada_collection publication
open_canada_date_published 2021-03-30 00:00:00
open_canada_keywords {"fr": ["coronavirus", "COVID-19", "pandémie", "médicaments", "médicaments", "vaccins", "autorisation de mise en marché", "licence", "importation ou vente", "vaccin COVID-19", "soumissions continues", "exigences non cliniques", "exigences cliniques"], "en": ["coronavirus", "COVID-19", "pandemic", "drugs", "medications", "vaccines", "market authorization", "licensing", "importing or selling", "COVID-19 vaccine", "rolling submissions", "non-clinical requirements", "clinical requirements"]}
open_canada_subject ["health_and_safety"]
sensitivity_level unrestricted
title_fr Lignes directrices sur les exigences relatives aux autorisations de mise en marché des vaccins contre la COVID-19 : Présentations en continu, exigences non cliniques et cliniques
update_frequency as_needed