Description

This guidance helps sponsors interpret amendments to the Food and Drug Regulations (regulations) that allow a sponsor to apply for rolling review status for a forthcoming drug submission that meets specific eligibility conditions.

Resources

Name	Format	Description	Link
Draft guidance on management of rolling reviews for drug submissions: Overview	HTML		https://www.canada.ca/en/health-canada/programs/consultation-proposed-agile-regulations-guidance-licensing-drugs-medical-devices/draft-management-rolling-reviews-submissions.html
Draft guidance on management of rolling reviews for drug submissions: Overview	HTML		https://www.canada.ca/fr/sante-canada/programmes/consultation-projet-reglementation-souple-lignes-directrices-homologation-medicaments-instruments-medicaux/ebauche-gestion-examens-continu-presentations.html

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