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Industry Perspectives on Implementation of Model Master File (MMF) Framework for Generics and Innovator Drugs:
Sivacharan Kollipara1, Markus Friden2, Tycho Heimbach3
1Biopharmaceutics Group, Global Clinical Management, Integrated Product Development Organization (IPDO), Dr. Reddy's Laboratories Ltd, Medchal Malkajgiri District, Bachupally, 500 090, Telangana, India. sivacharankollipara@drreddys.com.
Pharmaceutical Research
|March 13, 2025
Summary
The model master file (MMF) streamlines regulatory submissions for drug development using modeling and simulation (M&S). Industry experts discussed MMF benefits, challenges, and applications for new and generic drugs.
Area of Science:
- Pharmaceutical Sciences
- Regulatory Science
- Computational Science
Background:
- Modeling and simulation (M&S) approaches are vital in drug development.
- The model master file (MMF) concept facilitates regulatory submissions and M&S use.
- Approved MMFs offer reusability, shareability, and portability across submissions.
Purpose of the Study:
- To explore industry perspectives on implementing MMFs in drug development.
- To discuss potential applications, challenges, and benefits of MMFs.
- To understand industry thinking on MMFs during drug discovery and development.
Main Methods:
- Summarized industry perspectives from a public workshop co-hosted by USFDA and CRCG.
- Utilized diverse case studies to discuss MMF implementation.
- Presented views from industry participants on MMF concept and its use.
Main Results:
- MMFs can reduce applicant effort and regulatory review timelines.
- MMFs enhance efficiency by being reusable and sharable.
- Industry participants shared insights on MMF opportunities and challenges.
Conclusions:
- MMFs represent a significant advancement in streamlining regulatory processes for M&S.
- Industry engagement is crucial for successful MMF implementation in drug discovery and development.
- The MMF framework holds promise for both new and generic drug product development.
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