Guidance for market authorization requirements for COVID-19 drugs: Rolling submissions and reviews

Guidance for market authorization requirements for COVID-19 drugs: Rolling submissions and reviews 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). The ability to review data from early development while later-stage clinical trials are taking place helps to expedite the regulatory review process. 2022-07-28 Health Canada open-ouvert@tbs-sct.gc.ca Health and SafetyCOVID-19COVID-19 drugsmarket authorization requirementsdrug manufacturedsoldregulatory processrolling submissions-and-reviews Guidance for market authorization requirements for COVID-19 drugs: Rolling submissions and reviewsHTML https://www.canada.ca/en/health-canada/services/drugs-health-products/covid19-industry/drugs-vaccines-treatments/guidance-market-authorization-drugs/rolling-submissions-reviews.html Guidance for market authorization requirements for COVID-19 drugs: Rolling submissions and reviewsHTML https://www.canada.ca/fr/sante-canada/services/medicaments-produits-sante/covid19-industrie/medicaments-vaccins-traitements/lignes-directrices-autorisations-mise-marche-medicaments/presentations-continu-examens.html

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). The ability to review data from early development while later-stage clinical trials are taking place helps to expedite the regulatory review process.

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