UK Launches Decentralised Manufacturing Framework for Innovative Medicines

The UK’s new Decentralised Manufacturing (DM) framework came into effect on 23 July 2025 under The Human Medicines (Amendment) (Modular Manufacture and Point of Care) Regulations 2025. The legislation aims to enable faster access to personalised, lifesaving treatments while maintaining established standards of quality, safety, and efficacy.

The MHRA led a cross-disciplinary effort—including GMP inspectors, clinical trial assessors, pharmacovigilance experts, and scientists—to develop guidance and respond to stakeholder queries. The framework expands options beyond traditional centralised manufacturing but requires robust justification of clinical benefit before DM designation is granted.

DM readiness relies on three pillars: regulatory, institutional, and technical, ensuring that products and processes consistently meet GMP standards even in novel settings. Control sites must hold appropriate manufacturing licences, maintain a Decentralised Manufacturing Master File, and be inspection-ready.

While centralised manufacture remains the default, Point of Care (POC) and Modular Manufacturing (MM) may be approved to overcome short shelf life or deployment challenges. The MHRA will continue refining guidance as experience with DM grows.

For updates, visit the Decentralised Manufacture Hub.

01-10-2025