Description

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.

Resources

Name	Format	Description	Link
Guidance for market authorization requirements for COVID-19 drugs: Rolling submissions and reviews	HTML		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 reviews	HTML		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

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