Notice: Revision to the Guidance Document: Management of Drug Submissions and Applications (English, HTML)

View metadata and access the original English HTML file: Notice: Revision to the Guidance Document: Management of Drug Submissions and Applications.

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2021-12-29

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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