Decentralized Manufacturing (DM): A New Era for Medicines and Healthcare

Pharmaceutical manufacturing is entering a new era—one defined by flexibility, personalization, and resilience—driven by the MHRA’s groundbreaking DM framework. This innovative approach responds to disruptive changes in science and technology, enabling new models such as Point-of-Care (POC) and Modular Manufacture (MM) while safeguarding quality, safety, and efficacy. By decentralizing production, MHRA aims to create a more agile, patient-centric system that can adapt to emerging healthcare needs and accelerate access to life-saving therapies.

In a presentation at the 2025 ISPE Annual Meeting & Expo on 27 October, Ian Rees of the MHRA, which regulates medicines, devices, and blood for transfusion, explained that the MHRA has adapted its legal and guidance frameworks to keep pace with disruptive scientific and technological advancements. This involved a decade-long process—accelerated during the pandemic—of consultations, workshops, and legislative updates to enable advanced manufacturing models, including decentralized and point-of-care production. Key innovations include introducing legal tests for modular and point-of-care manufacturing, creating a central control site for quality oversight, and developing a Decentralized Manufacturing Master File (DMMF) for dynamic site authorization. The updated guidance aims to remain proportionate and flexible while supporting innovation without undermining traditional centralized models, with future considerations focused on institutional readiness and rapid scale-up for scenarios like pandemics.

The Future of Pharmaceutical Manufacturing Is Here

The MHRA is spearheading a transformative shift in how medicines are made. With the introduction of the DM framework, the industry is moving beyond traditional factory-based models to embrace agile, patient-centric approaches.

This evolution responds to disruptive changes in science and technology, enabling new models such as POC and MM, while maintaining the highest standards of quality, safety, and efficacy.

Why Decentralized Manufacturing?

Rees stated that traditional factory-based models are well-suited for stable, large-scale production, but they struggle to meet the demands of personalized medicine, short shelf-life products, and rapid deployment scenarios such as pandemics or emergency responses. DM broadens the spectrum of manufacturing options, supporting flexibility without compromising standards.

The framework introduces a hub-and-spoke model, where a central control site oversees quality systems, training, and compliance, while remote sites operate under a DMMF. This structure ensures consistency across multiple locations while enabling faster, localized production closer to patients.

Traditional manufacturing excels at large-scale, stable production. But what about personalized therapies, short shelf-life products, or emergency deployment? These scenarios demand flexibility.

The DM framework introduces a hub-and-spoke model:

• A central control site manages quality systems, training, and compliance.
• Remote sites operate under a DMMF, ensuring consistency across the network

The Legal Backbone

In January 2025, the UK enacted the Human Medicines (Amendment) Regulations, creating a legal foundation for DM. These changes include legal tests for POC and MM manufacturing, ensuring that decentralization is justified by product characteristics or deployment needs. A streamlined designation process provides clarity and speed, allowing companies to secure MHRA approval within 60–90 days—a significant improvement over traditional timelines.

Guidance and Support for Industry

To help stakeholders navigate this new landscape, MHRA launched the DM Hub, a one-stop resource for legislation, guidance documents, case studies, and webinars. Guidance addresses unique challenges such as:

• Managing multiple manufacturing sites under one quality system
• Implementing real-time release testing
• Leveraging automation for home-use and personalized products
• Legislation and guidance documents
• Case studies and best practices
• Webinars and training sessions

This proactive support ensures that organizations can adopt DM confidently and in compliance with regulatory expectations.

Global Collaboration

Innovation doesn’t stop at borders. MHRA is working with international partners through ICMRA, PIC/S, and IPRP to harmonize terminology, technical standards, and regulatory approaches worldwide. This ensures that decentralized models can scale globally without compromising patient safety. This global alignment ensures that innovation can scale across borders while maintaining patient safety and fostering trust in decentralized models worldwide.

The Three Pillars of Success

Rees highlighted in his presentation that adopting DM requires more than regulatory change. Success depends on:

• Regulatory readiness: Robust legislation and clear guidance
• Technical readiness: Adaptable products and processes
• Institutional readiness: Organizations prepared to embrace new models

MHRA encourages early engagement through its Innovation Office and Scientific Advice Meetings to help companies prepare for this exciting future.

Why This Matters

DM isn’t just a regulatory update, it’s a paradigm shift. It empowers faster access to medicines, supports personalized care, and strengthens resilience in global health systems.

Conclusion

Rees concluded that DM represents far more than a regulatory update—it is a fundamental transformation in pharmaceutical production that combines legal innovation, technical adaptability, and global collaboration. By enabling point-of-care and modular manufacturing under robust oversight, this framework accelerates patient access to life-saving medicines, supports personalized therapies, and strengthens resilience against future health crises. Organizations that embrace this model will not only meet evolving regulatory expectations but also lead the way in shaping a more agile, patient-centric healthcare ecosystem.