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

This report summarizes the proceedings of Session 2 of the two-day public workshop titled "Considerations and Potential Regulatory Applications for a Model Master File" hosted by the U.S. Food and Drug Administration (FDA) and the Center for Research on Complex Generics (CRCG) on May 2-3, 2024. The workshop aimed to discuss the frameworks and practical considerations for developing a model master file (MMF) and its applications to support drug product development and streamline regulatory review processes. This report provides a comprehensive and insightful overview of the second session of the workshop titled "MMF Applications for Oral Dosage Forms". The presentations, which included several case studies, covered potential frameworks and context of use (COU) of MMFs for oral drug products, practical considerations during model development, validation, and regulatory submission processes, as well as scientific justification for modification on approved MMFs. Additionally, the discussion highlighted the crucial role of global harmonization of MMFs, which can benefit both industry and regulatory authorities by making modeling more resource- and time-efficient while meeting high regulatory standards, ultimately reducing delays in drug development and accelerating the availability of new medicines. MMFs for oral dosage forms are especially advantageous due to the wealth of global resources from various organizations and the opportunity to extend these capabilities to complex generics. Lastly, the session also discussed the potential for using technology to track the lifecycle of accepted MMFs, enabling adaptations and ensuring transparency in their downstream reuse.