Draft guidance on management of rolling reviews for drug submissions: Rolling review process, eligibility

Draft guidance on management of rolling reviews for drug submissions: Rolling review process, eligibility Health Canada is offering an option for a rolling review of a new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. 2023-09-01 Health Canada open-ouvert@tbs-sct.gc.ca Health and Safetydrug submissionsmanagement-of-rolling reviewsdrug submissionsrolling review processeligibility Draft guidance on management of rolling reviews for drug submissions: Rolling review process, eligibilityHTML 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Draft guidance on management of rolling reviews for drug submissions: Rolling review process, eligibilityHTML 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

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.

Data and Resources

Similar records