Using Model Master Files to Support Oral Drug Product Development and Regulatory Submissions

Area of Science:

• Pharmaceutical Sciences
• Regulatory Science
• Computational Chemistry

Background:

• The U.S. Food and Drug Administration (FDA) and Center for Research on Complex Generics (CRCG) hosted a workshop on Model Master Files (MMFs).
• MMFs are proposed as a tool to support drug product development and expedite regulatory reviews.
• Session 2 focused specifically on the applications of MMFs for oral dosage forms.

Purpose of the Study:

• To summarize the discussions and findings from Session 2 of the MMF workshop.
• To explore frameworks, practical considerations, and regulatory applications of MMFs for oral drug products.
• To highlight the benefits of global harmonization and technological advancements in MMF utilization.

Main Methods:

• Summarizing proceedings from a public workshop.
• Reviewing presentations and case studies on MMFs for oral dosage forms.
• Analyzing discussions on MMF development, validation, submission, and lifecycle management.

Main Results:

• MMFs offer potential frameworks and context of use (COU) for oral drug products.
• Practical considerations for MMF development, validation, and regulatory submissions were discussed.
• Global harmonization of MMFs can enhance efficiency and reduce drug development timelines.
• Technology can track MMF lifecycles, ensuring transparency and facilitating reuse.

Conclusions:

• MMFs, particularly for oral dosage forms, present significant advantages for drug development and regulatory processes.
• Global harmonization of MMFs is crucial for resource and time efficiency.
• Technological solutions for MMF lifecycle management can improve transparency and downstream reuse, accelerating medicine availability.