The UK Government has made history by enacting the world's first dedicated legal framework for manufacturing personalized medicines at the point of care, potentially transforming how patients receive life-saving therapies. The Human Medicines (Amendment) (Modular Manufacture and Point of Care) Regulations 2025, introduced by the Medicines and Healthcare products Regulatory Agency (MHRA), allows hospitals, clinics, and local care settings to complete final manufacturing steps for advanced therapies directly where patients are treated.
Revolutionary Approach to Treatment Delivery
The groundbreaking legislation addresses a critical bottleneck in personalized medicine delivery. Currently, therapies are manufactured in centralized laboratories, creating extended vein-to-vein timeframes due to shipping requirements. Under the new framework, patients can receive treatments made at their hospital, clinic, or near their homes, reducing delivery times from months to potentially just days.
"This world-first legislation is a game-changer for patients. Cancer treatments tailored in days, not months. Life-saving therapies made at your bedside, not hundreds of miles away," stated UK Health and Social Care Secretary Wes Streeting.
Comprehensive Therapeutic Coverage
The legislation encompasses a broad range of advanced therapeutic products, including cell and gene therapies, tissue-engineered treatments, 3D-printed products, blood products, and medicinal gases. The framework also supports mobile manufacturing units, offering close-to-home treatment options for patients too unwell to travel or whose compromised immune systems make hospital visits particularly risky.
Addressing Critical Treatment Challenges
The new approach directly tackles significant challenges in CAR-T therapy delivery. By accelerating manufacturing timelines, the legislation can reduce instances where patients become too unwell to receive therapy during extended waiting periods. Additionally, it addresses situations where medicines' short shelf lives previously meant treatments could not be administered by the time they reached patients.
Industry and Regulatory Support
Cell and Gene Therapy Catapult chief executive Matthew Durdy praised the initiative, stating: "This change demonstrates how the MHRA is leading in the UK's commitment to being at the forefront of modern healthcare, innovation and regulation. The MHRA has recognised that some practices are better with more flexibility, and that in a technology-enabled world which allows better training, information and communication, flexibility can be enabled without compromising safety."
Durdy emphasized the broader implications: "This is not just a step forward for innovative medicines such as cell and gene therapies; it is a step towards enabling truly personalised medicine. We applaud this change introduced by the MHRA and look forward to a future where more patients can receive therapeutics tailored to their needs, quickly, cost-effectively and sustainably."
Regulatory Framework and Oversight
The MHRA will maintain oversight through a central control site while allowing hospitals, ambulances, and local care settings to complete final manufacturing steps using regulated protocols. The agency has also issued guidance developed in collaboration with other UK regulators, the National Health Service, industry stakeholders, and healthcare professionals to clarify practical implementation of the legislation.
Strategic Healthcare Initiative
This legislation represents a key component of the NHS 10-year plan announced by Secretary Streeting and UK Prime Minister Keir Starmer. The initiative positions the UK as a global leader in healthcare innovation and regulation, potentially setting a precedent for other countries seeking to improve access to personalized therapies.
Decentralized manufacturing has previously been recognized as an emerging development in the cell and gene therapy sector, though implementation has been limited by the high costs associated with establishing these processes. The UK's regulatory framework now provides the legal foundation necessary to realize these manufacturing innovations at scale.
