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The Government has published a response to the consultation on proposals to support the regulation of medicines manufactured at the Point of Care.
New types of innovative products are increasingly being manufactured at the point where a patient receives care e.g. personalised medicines made for the patient either within or very close to the healthcare setting.
The proposed POC framework is specifically designed to create and regulate a step change in the range of manufacturing options to enable the supply and increase the availability of innovative new medicinal products to patients. This new manufacturing and supply system in the UK healthcare system will benefit patients that currently have no or few treatment options by improving the availability of innovative medicines.
We are proposing a regulatory framework that is based on and links into current regulatory systems for medicines approvals, clinical trials, evaluation of regulatory compliance at manufacturing sites and safety monitoring.
The aim is to support increased manufacture of point of care products whilst ensuring these products attain the same assurance of safety, quality and efficacy currently in place for more conventional medicinal products.
We’d value your views to help shape the introduction of a new regulatory framework for products supplied at the point of care and welcome you to respond to our questions using the link here. In answering these questions, please also consider the wider aspects of this proposed change including any links to or impact on related regulated areas.
The consultation is open from 9:00am on 12 August 2021 until 11:45pm on 23 September 2021. We will consider all your comments as quickly as possible and use them to inform the drafting of our legislative proposals thereafter.