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.
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.
