Description

To apply for rolling review status for a forthcoming new drug submission (NDS) or supplement to a new drug submission (SNDS), sponsors must provide a Rolling Review Application Package (RRAP). The RRAP is forwarded to the appropriate directorate and assessed within 45 calendar days.

Resources

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Draft guidance on management of rolling reviews for drug submissions: Applying for rolling review status	HTML	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Draft guidance on management of rolling reviews for drug submissions: Applying for rolling review status	HTML	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

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