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Lucy Chard
26 Jan 2023

UK creates new regulations to achieve more accessible care

The UK Medicines and Healthcare products Regulatory Agency have approved an innovative framework to enable seamless use of Point of Care products that will benefit patients. 

The UK is introducing a new model for the regulation of products manufactured on site of care. As the first country to do so, this will revolutionise medical professionals’ ability to treat patients in a more timely way.

It also means that medicines with a short shelf life, or are highly personalised, are much more accessible to patients in immediate need. The Medicines and Healthcare products Regulatory Agency (MHRA) has approved the new framework. 

In normal practice, innovative products have to go pass strict regulations, ensuring the quality, safety and effectiveness of the product before it can be used to treat patients. The new framework still guarantees this same level of assurances, but with the added benefit of the medicines being so much closer to home. 

This new system comes after the MHRA conducted a survey of individuals, organisations and stake holders in the UK about Point of Care (POC) products. The feedback was that these medicines are vital, can be extremely varied, and traditional regulations aren’t always applicable to make sure the best care reaches the patients. Therefore, a new framework was needed. 

The benefits of a new set of regulations for POC manufacturing would be demonstrated with patients, by giving more personalised and timely care; with healthcare professionals by providing a greater range of treatment options, whilst increasing patient compliance; and with innovators, who will now have a clear set of guidelines to follow in development and manufacturing. 

The ground-breaking framework will be applicable to all POC products manufactured in the UK all POC products manufactured in the UK including advanced therapeutics. Before the framework can be implemented however, guidance will have to be developed and legislation updated – including the UK’s Human Medicines and Clinical Trials legislation – in Parliament later in the year. 

International regulatory bodies are also looking at the UK’s new framework to see if it can be translated to help in similar situations in other countries. 

Ian Rees, MHRA Point of Care manufacturing lead, commented:

"As a regulator that champions innovation, we are delighted that our stakeholders are overwhelmingly supportive of introducing a fit-for-purpose UK legislative framework for Point of Care manufacturing.
When implemented, these changes will drive tangible benefits for patients, with visible differences at the product innovation stage right up to the point of care, which will allow easier access to a greater and more personalised range of treatments for those in need.
The accompanying guidance for the legislation will be absolutely critical for its implementation and interpretation, and we will ensure that there is effective engagement and dialogue with stakeholders to make this exciting framework a reality for people across the UK". 

UK Health Minister Will Quince also noted:

"Patients, carers and healthcare staff across the country will benefit from this landmark initiative which will give them quicker access to innovative and personalised treatments closer to home. The UK is a world leader in medicines and this work we are spearheading will break down unnecessary regulatory barriers and free up hospital beds, while easing pressure on the health service". 

Lucy Chard
Digital Editor - Pharma

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