Draft guidance on management of rolling reviews for drug submissions: Performance targets and standards, cancellation

Draft guidance on management of rolling reviews for drug submissions: Performance targets and standards, cancellation The time to complete the screening of a drug submission with a rolling review is 25 days. Once the screening acceptance letter is issued, the review 1 period would begin. The submission would immediately be placed on “rolling review” until Health Canada receives all of the missing information, as indicated in the notice. 2023-09-01 Health Canada open-ouvert@tbs-sct.gc.ca Health and Safetydrug submissionsmanagement-of-rolling reviewsdrug submissionsperformance targets-and-standardscancellation Draft guidance on management of rolling reviews for drug submissions: Performance targets and standards, cancellationHTML https://www.canada.ca/en/health-canada/programs/consultation-proposed-agile-regulations-guidance-licensing-drugs-medical-devices/draft-management-rolling-reviews-submissions/performance-targets-standards-cancellation.html Draft guidance on management of rolling reviews for drug submissions: Performance targets and standards, cancellationHTML https://www.canada.ca/fr/sante-canada/programmes/consultation-projet-reglementation-souple-lignes-directrices-homologation-medicaments-instruments-medicaux/ebauche-gestion-examens-continu-presentations/objectifs-normes-rendement-annulation.html

The time to complete the screening of a drug submission with a rolling review is 25 days. Once the screening acceptance letter is issued, the review 1 period would begin. The submission would immediately be placed on “rolling review” until Health Canada receives all of the missing information, as indicated in the notice.

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