UK leads on new regulatory framework for point-of-care medicine manufacturing 6 Feb 2023
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has announced the establishment of a ground-breaking regulatory framework to simplify the manufacture of innovative medicines at the point of care. The UK’s Human Medicines and Clinical Trials legislation will be amended to enable this and brought to parliament later in 2023.
This means that the manufacture of new medicines with short shelf lives and highly personalised medicines will have a smoother path to the patient, unencumbered by regulatory barriers, but with the same safety, quality and effectiveness as required for conventional medicinal products.
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