Description

Health Canada is offering an option for a rolling review of a new drug submission (NDS) or supplement to a new drug submission (SNDS) that meets specific eligibility conditions. Sponsors nearing the end of clinical development of a drug can apply to Health Canada for rolling review status for a forthcoming drug submission.

Resources

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Draft guidance on management of rolling reviews for drug submissions: Rolling review process, eligibility	HTML	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Draft guidance on management of rolling reviews for drug submissions: Rolling review process, eligibility	HTML	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

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