Health Canada: Guidance Document Management of Drug Submissions and Applications & Post-DIN Changes

Health Canada on August 2, 2022, revised the Guidance Document entitled: The Management of Drug Submissions and Applications (MDSA).

This guidance provides guidance regarding the way in which drug submissions, applications or post-market documents submitted to Health Canada are managed. 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.

Also, Health Canada revised its Post-Drug Identification Number (DIN) Changes Guidance.

All drugs subject to the Food and Drug Regulations are required to gain premarket authorization prior to issuance of a Drug Identification Number (DIN).

After gaining authorization to market a drug a sponsor may for various reasons wish to make changes to the drug or the information associated with the drug. This guidance is intended to advise both internal and external stakeholders regarding the filing requirements for postmarket changes and the data recommendations to support those changes.