Canada – Guidance Document: Management of Drug Submissions and Applications – Revisions

Health Canada revised the Guidance Document entitled: The Management of Drug Submissions and Applications (MDSG). This document provides sponsors and Health Canada staff of the Therapeutic Products Directorate, the Biologic and Genetic Therapies Directorate, the Natural and Non-Prescription Health Products Directorate (Non-Prescription Drugs Evaluation Division), the Marketed Health Products Directorate and the Resource Management and Operations Directorate (Office of Submissions and Intellectual Property) 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 its Regulations.

There has not been a major revision to the MDSG since 1993. In October 2018, Health Canada provided notice of its intent to update the MDSG and consulted on specific changes to the Guidance in the “Notice: Consultation on proposed revisions to the Guidance Document: Management of Drug Submissions” (the Notice). The Notice was posted for a 30-day consultation period.

The guidance is being updated at this time to reflect the some of the outcomes of the above consultation and to provide updated information on the processes and procedures relevant to the filing of a submission or application. The information in the guidance was reorganised to mirror the process that submissions and applications or post market pharmacovigilance documents submitted to Health Canada follow. In addition to the general updates, the following changes were made…