Notice: Revision to the Guidance Document: Management of Drug Submissions and Applications

Notice: Revision to the Guidance Document: Management of Drug Submissions and Applications Health Canada is revising the Guidance Document entitled: The Management of Drug Submissions and Applications (MDSA). This document provides sponsors and Health Canada staff of the Therapeutic Products Directorate, the Biologic and Radiopharmaceutical Drugs Directorate, the Natural and Non-Prescription Health Products Directorate (Non-Prescription Drugs Evaluation Division), and the Marketed Health Products Directorate with operational direction and guidance regarding the way in which drug submissions, applications or post-market documents submitted to Health Canada are managed. 2021-12-29 Health Canada open-ouvert@tbs-sct.gc.ca Health and Safetyrevising guidance documentdrug submissionsdrug applicationspost-market documents submissionsoperational direction Notice: Revision to the Guidance Document: Management of Drug Submissions and ApplicationsHTML https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/announcements/notice-revision-guidance-document-management-drug-submissions-applications.html Notice: Revision to the Guidance Document: Management of Drug Submissions and ApplicationsHTML https://www.canada.ca/fr/sante-canada/services/medicaments-produits-sante/medicaments/annonces/avis-revision-ligne-directrice-gestion-presentations-demandes-drogue.html

Health Canada is revising the Guidance Document entitled: The Management of Drug Submissions and Applications (MDSA). This document provides sponsors and Health Canada staff of the Therapeutic Products Directorate, the Biologic and Radiopharmaceutical Drugs Directorate, the Natural and Non-Prescription Health Products Directorate (Non-Prescription Drugs Evaluation Division), and the Marketed Health Products Directorate with operational direction and guidance regarding the way in which drug submissions, applications or post-market documents submitted to Health Canada are managed.

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