Health Canada Drug Master File (DMF) Submission - Overview

The Health Canada Drug Master File (DMF) is a document submitted to Health Canada to provide important information about an Active Pharmaceutical Ingredient (API), finished dosage form, excipients & container closure systems, and processes used in the manufacturing, processing, packaging, and storing of human drugs. It is submitted to support the drug application.

ANDA Post-approval Change Submissions - Overview

ANDA post-approval changes must be submitted to Health Canada (HC) as a supplement/amendment/annual report based on the complexity and impact on the quality of the product as per the HC guidelines.

Based on the impact of the change, the reporting categories of the Canada ANDA post-approval changes are as follows:

Health Canada’s Regulatory Strategic Guidance - Overview

Generic manufacturers face challenges such as understanding the complexity of Canada’s drug registration guidelines for generic drug approval through an Abbreviated New Drug Submission (ANDS) and complying with the respective guidelines. To overcome them, manufacturers must adopt a robust approach for different types of medicinal products and ensure timely registration and approvals.

Canada Health Authority Interactions - Overview

Regulatory agency interactions are key in achieving a positive impact on the approval timelines and overall costs. Since the final decision on drug product approvals lies with Health Canada, it is important to ensure that the interactions with the Agency (whether face-to-face, in writing, or via teleconference) are conducted efficiently throughout the Regulatory process.

Change Control Evaluation and Submission Strategy - Overview

A strong Submission Strategy is crucial for managing changes that impact the approved content of the application. Such changes necessitate a comprehensive assessment to ascertain the most suitable course of action.

Health Canada ANDS - Overview

Abbreviated New Drug Submission (ANDS) is the application submitted to Health Canada for the review and approval of generic drugs against the Canadian Reference Product (CRP).

Refuse-to-Receive Practices - Overview

To ensure content consistency, reduce the time spent by the United States Food and Drug Administration (FDA) reviewers, and minimize the approval timelines for an ANDA, the FDA has set up ANDA Refuse-to-Receive (RTR) guidelines which are vital to the manufacturers/ANDA-holders to be compliant.