UK Introduces World-First Framework for Point-of-Care Advanced Therapies Manufacturing

The United Kingdom enacted new legislation today that establishes a regulatory framework for the on-site manufacture of advanced therapies, including cell and gene therapies. The new approach aims to significantly expand access and reduce wait times for these personalized treatments.

The Human Medicines (Amendment) (Modular Manufacture and Point of Care) Regulations 2025, introduced by the U.K.’s Medicines and Healthcare products Regulatory Agency (MHRA), allow hospitals, ambulances and local care settings to complete final manufacturing steps at the point of care using regulated protocols. The legislation also supports mobile manufacturing units and applies to a wide range of products, including tissue-engineered treatments, blood products, 3D-printed therapies and medicinal gases. MHRA will provide oversight through a central control site.

In addition, MHRA issued guidance developed in collaboration with other U.K. regulators, the National Health Service, industry and health care professionals to clarify how the legislation applies in practice.