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

July 25 2019
Our file number: 19-112562-576

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:

• Removed the sections relating to Update Notices and Advance Notice Letters, as the Notice and Letter are no longer used given the objective of the Department to review within the current performance target standards.
• Removed paragraphs regarding information that must be submitted within 180 days of the original submission under Section 14- Unsolicited Information.
• Amended the existing 15-day standard timeline for responses to clarification requests to account for the type of submission or level of clarification being requested (Section 12.1.2)

For more detailed information on the changes and additions that were made, please consult the document change log within the Guidance document. This guidance document comes into effect immediately.

Questions or concerns related to this guidance document should be directed to:

Bureau of Policy, Science and International Programs
Therapeutic Products Directorate
Health Canada
Address Locator 3102C1
Holland Cross, Tower B
1600 Scott Street
Ottawa, Ontario
K1A 0K9

Telephone: 613-948-4623
Facsimile: 613-941-1812
E-mail: hc.policy.bureau.enquiries.sc@canada.ca