Cheng Yi-Hsien, Pal Arindom, Moody Rebecca, Heimbach Tycho, Lukacova Viera, Patel Nikunjkumar, Rullo Gregory, Xu Yunming, Ahmed Tausif, Kerwash Essam, Fang Lanyan, Wu Fang
Office of Research and Standards (ORS), Office of Generic Drugs (OGD), Center for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration (FDA), Silver Spring, Maryland, USA.
Office of Product Quality Assessment (OPQA), Office of Pharmaceutical Quality (OPQ), CDER, U.S. FDA, Silver Spring, Maryland, USA.
Pharm Res. 2025 May 29. doi: 10.1007/s11095-025-03865-9.
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.
本报告总结了2024年5月2日至3日由美国食品药品监督管理局（FDA）和复杂仿制药研究中心（CRCG）主办的为期两天的公开研讨会第二场会议的议程。该研讨会旨在讨论开发模型主文件（MMF）的框架和实际考量因素，以及其在支持药品开发和简化监管审查流程方面的应用。本报告全面且深入地概述了题为“口服剂型的MMF应用”的研讨会第二场会议。演讲内容包括多个案例研究，涵盖了口服药品MMF的潜在框架和使用背景（COU）、模型开发、验证及监管提交过程中的实际考量因素，以及已批准MMF修改的科学依据。此外，讨论强调了MMF全球协调的关键作用，这可以通过提高建模的资源和时间效率，同时满足高监管标准，使行业和监管机构都受益，最终减少药物开发延迟并加速新药上市。由于各组织拥有丰富的全球资源，且有机会将这些能力扩展到复杂仿制药，口服剂型的MMF尤其具有优势。最后，会议还讨论了利用技术跟踪已接受MMF生命周期的可能性，以实现适应性调整并确保其下游再利用的透明度。
