Regulator seeks views on innovative medicines manufacture at point of care

The Medicines and Healthcare products Regulatory Agency (MHRA) is launching a consultation on a proposed regulatory framework for Point of Care (POC) manufacturing.

POC manufacturing refers to the manufacture of personalised medicines made for the patient either within or very close to where they are receiving care, for example, an operating theatre, ambulance or a military hospital. Many POC products have a short shelf life – some need to be used within minutes - so they cannot be manufactured in advance or supplied from a distance.

POC products include some types of Advanced Therapy Medicinal Products, for example cell therapy, gene therapy and tissue engineered products; 3D printed products, which might include patient specific prosthetics; blood products and medicinal gasses.

MHRA Chief Quality and Access Officer, Sam Atkinson, commented:

Patient safety is our absolute priority and we are committed to ensuring that regulation keeps pace with rapid technological advancements and disruptive innovations. The MHRA is keen to support the increased manufacture of point of care products whilst ensuring they have the same assurance of safety, quality and efficacy currently in place as for more conventional medicinal products.

We are seeking the views and expertise of industry and the medical community and, crucially, patients and the public, ensuring their views and interests are at the heart of our decision-making.

The public consultation will run for six weeks from 12 August 2021. Find out more and help us shape future regulation by sharing your views here.

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