UK to introduce first-of-its-kind framework to make it easier to manufacture innovative medicines at the point of care

The UK will be the first country to introduce a tailored framework for the regulation of innovative products manufactured at the point where a patient receives care, the Medicines and Healthcare products Regulatory Agency (MHRA) has announced today. This will mean that new medicines with very short shelf lives and highly personalised medicines can more easily be made in or near a hospital setting or ambulance and can get to the patients who need them much more quickly.

The new framework will ensure there are no regulatory barriers to innovative manufacturing and that products made via such routes have the same assurances of safety, quality, and effectiveness as those for conventional medicinal products. This follows a public consultation carried out by the MHRA which heard from a range of individuals and organisations across the UK and internationally. In describing their experience with Point of Care (POC) products, responders highlighted the urgent need to establish a regulatory framework for these vital and varied products.

The establishment of a regulatory framework for POC manufacturing would bring a range of benefits to:

• Patients and carers – by providing access to new and more personalised treatments in a timely and more convenient manner with the potential for less travel and time spent in hospitals.
• Healthcare professionals – by providing a greater range and more effective treatment options and improve patients’ adherence to those treatments.
• Innovators – by providing clear regulatory expectations and enabling easier product development.

Once implemented, this innovative framework will apply to all POC products manufactured in the UK, including a range of Advanced Therapy Medicinal Products, such as cell therapy, gene therapy and tissue engineered products; 3D printed products, blood products, and medicinal gasses.

Next steps

In order to implement this framework, new legislation is being developed to amend the UK’s Human Medicines and Clinical Trials legislation and will be brought to Parliament later this year. The MHRA will also begin to develop guidance, in conjunction with stakeholders, to accompany the new framework, which will be issued in due course.

Work has already started on a joined-up approach with other regulators within the UK and internationally to facilitate the development of equivalent regulatory processes and will continue in earnest throughout this process.

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

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.

Health Minister Will Quince said:

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.

View the full results of the public consultation and the government’s response to proposals for the regulation of medicines manufactured at the Point of Care.

Notes to Editors

• The Medicines and Healthcare products Regulatory Agency (MHRA) is responsible for regulating all medicines and medical devices in the UK by ensuring they work and are acceptably safe.  All our work is underpinned by robust and fact-based judgements to ensure that the benefits justify any risks.
• The MHRA is an executive agency of the Department of Health and Social Care.
• The Point of Care consultation ran for six weeks from 12 August 2021, and there were 51 responses (35 from organisations and 16 individual).
• Products manufactured at the POC are eligible for support through the MHRA ILAP pathway, which is in place to accelerate time to market and facilitate patient access.