Draft guidance on management of rolling reviews for drug submissions: Applying for rolling review status

Draft guidance on management of rolling reviews for drug submissions: Applying for rolling review status To apply for rolling review status for a forthcoming new drug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. 2023-09-01 Health Canada open-ouvert@tbs-sct.gc.ca Health and Safetydrug submissionsmanagement-of-rolling reviewsdrug submissionsapplying for rolling-review-status Draft guidance on management of rolling reviews for drug submissions: Applying for rolling review statusHTML 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Draft guidance on management of rolling reviews for drug submissions: Applying for rolling review statusHTML 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

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.

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