Guidance for market authorization requirements for COVID-19 drugs: Quality and manufacturing requirements

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

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Champ Valeur
Dernière modification avril 17, 2026, 17:51 (TU)
Créé le avril 17, 2026, 17:51 (TU)
criticality_level []
geographic_scope []
open_canada_collection publication
open_canada_date_published 2021-10-29 00:00:00
open_canada_keywords {"fr": ["COVID-19", "médicaments COVID-19", "exigences d'autorisation de mise sur le marché", "médicament fabriqué", "vendu", "processus réglementaire", "exigences de fabrication", "exigences de qualité"], "en": ["COVID-19", "COVID-19 drugs", "market authorization requirements", "drug manufactured", "sold", "regulatory process", "manufacturing requirements", "quality 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 médicaments contre la COVID-19 : Exigences de qualité et de fabrication
update_frequency as_needed