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World first as life-saving cancer drugs to be mixed at patients' bedsides

SUMMARY

The UK has become the first country to allow hospitals to produce personalized cancer drugs at patients’ bedsides, following new regulations by the Medicines and Healthcare products Regulatory Agency (MHRA). These laws enable on-site manufacturing of bespoke treatments, slashing production times from months to days and improving outcomes for critically ill patients.

Previously, strict rules required specialized facilities, often distant, to modify patients’ cells for therapies like CAR-T, which reprograms immune cells to target cancer. Delays in transport could render drugs ineffective or patients too sick for treatment. “Some patients have become too unwell to receive their treatment in time. In others, the medicine simply didn’t survive the journey,” said MHRA chief executive Lawrence Tallon. Now, hospitals can complete final manufacturing steps on-site, adhering to strict standards. Mobile units will also deliver therapies to patients’ homes, aiding those with weakened immune systems. “Cancer treatments tailored in days, not months,” said Health Secretary Wes Streeting, calling it a “game-changer.”

The legislation, effective last month, covers cell and gene therapies, 3D-printed products, and more. A central control site ensures safety. This framework, Tallon noted, creates “a more flexible, responsive system that meets the needs of modern medicine.”


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