The UK Medicines and Healthcare products Regulatory Agency's (MHRA) new framework, which allows certain personalized innovative medicines to be administered at the point of care to patients, went into effect last week.
The new legislation allows personalized therapies to be prepared in small or individual batches – bringing care closer to the patient.
“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,” said UK Health and Social Care secretary Wes Streeting.
The regulatory framework supports increased manufacture and supply of new medicinal products manufactured at POC while ensuring that they retain equivalent levels of safety, quality and efficacy currently in place for medicinal products manufactured in factory-based locations. The framework, similar in concept to that established for control of blood products, delivers regulatory control of quality while delivering the necessary flexibilities for the product type.
The spectrum of manufacturing options, sometimes referred to as ‘distributed manufacture,’ includes a range of manufacturing categories such as POC, modular and mobile manufacturing.
The legislation, known as the Human Medicines (Amendment) (Modular Manufacture and Point of Care) Regulations 2025, makes the UK the first country in the world to introduce a dedicated legal framework for medicines made at the point of care. To support the implementation, the MHRA released new decentralized manufacturing guidelines last month.
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