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

July 7, 2021
Our file number: 21-112595-270

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. Specifically, it outlines and describes the processes and procedures to be followed to ensure consistency and transparency in the management of information and material submitted by sponsors to Health Canada in accordance with the Food and Drugs Act and the Food and Drug Regulations.

The guidance is being updated to reflect that joint reviews with other regulatory authorities are now in the scope of the Pause The Clock mechanism (Section 11.1.3).

Bureau of Policy, Science and International Programs
Therapeutic Products Directorate
Health Canada
Address Locator 3102C3
Holland Cross, Tower B
1600 Scott Street
Ottawa, Ontario
K1A 0K9

Telephone: 613-948-4623
Facsimile: 613-941-1812

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