Drug and vaccine authorizations for COVID-19: Overview

Drug and vaccine authorizations for COVID-19: Overview When a company decides it would like to sell a drug or vaccine in Canada, it files a submission with Health Canada. A new drug submission contains detailed scientific information about the drug's safety, efficacy and quality. Health Canada scientific reviewers evaluate data to assess the potential benefits and risks of a drug or vaccine. They also review the information that will be provided to health care practitioners and consumers about the product. After the review, we may authorize the drug or vaccine for sale in Canada only if the benefits of the product outweigh the potential risks. 2021-08-26 Health Canada open-ouvert@tbs-sct.gc.ca Health and SafetyCOVID-19drugsvaccinesdrug and vaccine authorizationsnew drug submissionsscientific informationdrug's safetyefficacy and qualityscientific reviewerspotential benefits and risksauthorize the drug or vaccine for sale Drug and vaccine authorizations for COVID-19: OverviewHTML https://www.canada.ca/en/health-canada/services/drugs-health-products/covid19-industry/drugs-vaccines-treatments/authorization.html Drug and vaccine authorizations for COVID-19: OverviewHTML https://www.canada.ca/fr/sante-canada/services/medicaments-produits-sante/covid19-industrie/medicaments-vaccins-traitements/autorisations.html

When a company decides it would like to sell a drug or vaccine in Canada, it files a submission with Health Canada. A new drug submission contains detailed scientific information about the drug's safety, efficacy and quality. Health Canada scientific reviewers evaluate data to assess the potential benefits and risks of a drug or vaccine. They also review the information that will be provided to health care practitioners and consumers about the product. After the review, we may authorize the drug or vaccine for sale in Canada only if the benefits of the product outweigh the potential risks.

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