UK’s ‘World First’ Point Of Care Manufacturing Rules Enter Parliament

The UK government has introduced draft legislation that will regulate the manufacturing of innovative medicines such as cell and gene therapies at the point of care. The country’s medicines regulator, the MHRA, says the framework is the “first of its kind in the world.”

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A UK regulatory framework that will enable medicines to be manufactured at the point of care (POC) or using modular manufacturing (MM) methods could be introduced from summer 2025, according to the Medicines and Healthcare products Regulatory Agency.

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