What You Must Know About Health Canada Master Files to Protect IP & Accelerate Approvals
Автор: Registrar Corp
Загружено: 2025-11-12
Просмотров: 12
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Health Canada Master Files (MFs) are a powerful tool for protecting proprietary information while streamlining regulatory submissions — but navigating their requirements can be complex. Understanding how to prepare, submit, and maintain a compliant Master File is essential to safeguard intellectual property, avoid costly delays, and accelerate product approvals in Canada’s competitive pharmaceutical product market.
In this webinar, you’ll gain clear, actionable guidance on:
-Master File Fundamentals – Definition, purpose, and the confidentiality advantage
-Global Acceptance – Which agencies accept Master Files
-Documentation Essentials – Administrative & quality requirements, Restricted vs. Applicant’s Part
-Cost Breakdown – Health Canada user fees and budgeting insights
-Submission Best Practices – Electronic formats, ESG NextGen secure gateway, and eCTD benefits
-Registrar Corp Support – Expert MF preparation, secure communication, and MyFDA portal tools
0:00 Introduction
2:05 Master Files
13:01 What is Needed to Keep a File Active?
16:27 MyFDA Solutions
17:36 Q&A
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