Decentralised Manufacturing: New UK Framework in Operation

The UK's new decentralised manufacturing (DM) framework, covering Point of Care (POC) and Modular Manufacturing (MM), came into force on 23 July 2025 under "The Human Medicines (Amendment) (Modular Manufacture and Point of Care) Regulations 2025". This legislation enables faster access to personalised, lifesaving treatments while upholding established standards of quality, safety and efficacy.

The UK Medicines and Healthcare Products Regulatory Agency (MHRA) has led a cross-disciplinary effort, spanning GMP inspectors, clinical trial and pharmacovigilance assessors, and scientists to develop supporting guidance and respond to stakeholder queries. The framework broadens manufacturing and supply options beyond traditional centralised models, but requires a robust justification of clinical benefit before DM designation is granted.

DM readiness rests on three pillars:

• Regulatory: new legislation and evolving guidance.
• Institutional: engagement with healthcare providers (notably the NHS), regulators and other key organisations.
• Technical: innovators must demonstrate that products and processes can consistently meet GMP standards in novel settings.

GMP requirements remain unchanged: the Control Site must hold an appropriate manufacturing licence, include a Decentralised Manufacturing Master File, and be prepared for inspection.

Centralised manufacture remains the default. Where POC or MM is justified, e.g. to overcome short shelf life or deployment barriers, the MHRA will continue to refine guidance and share learnings as the UK builds experience with this innovative manufacturing approach. For detailed guidance and updates, visit the Decentralised Manufacture Hub.