Industry Perspectives on Implementation of Model Master File (MMF) Framework for Generics and Innovator Drugs: Opportunities, Challenges and Future Outlook.

Abstract

Modeling and simulation (M&S) based approaches have proven significant utility in both new drug and generic product development. Considering the plethora of applications of such novel approaches, the concept of model master file (MMF) has been introduced recently to streamline the regulatory submission process as well as to facilitate the use of M&S approaches. The MMF has potential to reduce the applicant's efforts in preparing and submitting modeling-based applications and can result in reduced review timelines. Approved MMF's are considered as reusable, sharable, portable and generalizable and thus can be used by the same applicant in multiple submissions or by multiple applicants. To further increase the understanding of the MMF framework and to understand potential applications, and limitations, the USFDA and the Center for Research on Complex Generics (CRCG, https://www.complexgenerics.org ) co-hosted a hybrid public workshop titled "Considerations and Potential Regulatory Applications for a Model Master File". This article summarizes the industry perspectives of MMF implementation from both new drug and generic product development perspectives. With the help of diverse case studies, an effort was made in the manuscript to discuss potential challenges, opportunities and benefits. The objective of this article is to portray industry thinking on the MMF concept and the use and implementation of the concept during drug discovery and development. The views presented in this manuscript are of industry participants present at the workshop and not the industry at large.