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

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. 2022-07-28 Health Canada open-ouvert@tbs-sct.gc.ca Health and SafetyCOVID-19COVID-19 drugsmarket authorization requirementsdrug manufacturedsoldregulatory processmanufacturing requirementsquality requirements Guidance for market authorization requirements for COVID-19 drugs: Quality and manufacturing requirementsHTML https://www.canada.ca/en/health-canada/services/drugs-health-products/covid19-industry/drugs-vaccines-treatments/guidance-market-authorization-drugs/quality-manufacturing-requirements.html Guidance for market authorization requirements for COVID-19 drugs: Quality and manufacturing requirementsHTML https://www.canada.ca/fr/sante-canada/services/medicaments-produits-sante/covid19-industrie/medicaments-vaccins-traitements/lignes-directrices-autorisations-mise-marche-medicaments/exigences-qualite-fabrication.html

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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