MHRA seeks views on innovative medicines manufacture at point of care

The UK MHRA is seeking views on innovative medicines manufacture at point of care. It has launched a consultation on a proposed regulatory framework for Point of Care (POC) manufacturing.

What is 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.

Which product types are included as POC products?

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.

What is the consultation about?

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. Patient safety is the MHRAs absolute priority and they are committed to ensuring that regulation keeps pace with rapid technological advancements and disruptive innovations.

The consultation will help shape the introduction of a new regulatory framework for products supplied at the point of care.

Who is being consulted?

The MHRA is seeking the views and expertise of industry and the medical community and, crucially, patients and the public, ensuring that their views and interests are at the heart of MHRAs decision-making.

What are the start and end dates of the consultation?

The consultation will run for 6 weeks.

Start date: 12 August 2021

End date: 23 September 2021

Where can you respond to the consultation?

You can respond to the consultation here.

Source: MHRA website