Description

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.

Resources

Name	Format	Description	Link
Notice: Revision to the Guidance Document: Management of Drug Submissions and Applications	HTML		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 Applications	HTML		https://www.canada.ca/fr/sante-canada/services/medicaments-produits-sante/medicaments/annonces/avis-revision-ligne-directrice-gestion-presentations-demandes-drogue.html

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