Notice: Revision to the Guidance Document Management of Drug Submissions and Applications (August 2022)

August 2, 2022
Our file number: 22-107705-486

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 Pharmaceutical Drugs 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 & Food and Drug Regulations.

The guidance is being updated to reflect the following:

1. Defining the duration of a response to clarification request.
2. Removing the Submission Certification requirement for Responses to Submission Deficiency Notice (SDN), Notice of Deficiency (NOD) and Notice of Non-Compliance (NON).
3. Reflecting the updates made to the performance standards for Post-authorization Division 1 Changes (PDCs) for prescription pharmaceutical drugs and those administered or obtained through a health professional in the Guidance Document: Post-Drug Identification Number (DIN) Changes.

Questions or concerns should be directed to:

Bureau of Policy, Science and International Programs
Pharmaceutical Drugs Directorate, Health Products and Food Branch
E-mail: policy_bureau_enquiries@hc-sc.gc.ca