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 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.
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 is available here (insert
link).
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.
