A Statutory Instrument (SI) laid in Parliament today, 21 October,
will provide a new regulatory framework meaning that medicines
with a very short shelf life and highly personalised medicines
can more easily be made in or near a hospital setting and can get
to the patients who need them safely and much more quickly.
The regulation will also allow for manufacture of innovative
medicines in small, portable units that can be set up close to
patients who may be too sick to travel or whose reduced immunity
precludes travel or where rapid medicine availability is best
served.
This novel UK regulatory framework will transform patient
treatment by enabling the safe development of innovative,
personalised products such as cell or gene therapy that need to
be manufactured close to the individual patient.
It will help relieve pressures on hospitals by enabling delivery
of care where it is most appropriate for the patient, in
community settings or even in their homes, supporting the
ambition to expand ‘hospital at home' services such as virtual
wards.
IIan Rees, Point of Care lead at the MHRA, said:
“Enabling patients to safely access innovative treatments and
medicines is a top priority for the MHRA, which is why we have
developed this novel regulatory framework.
“This will enable new and innovative ways of manufacturing
medicines closer to the patients who need them whilst ensuring
their quality, safety and efficacy, with the consequent benefits
both to patients and the healthcare system.
“This totally new framework, the first of its kind in the world,
supports the MHRA's drive to deliver for patients; making it
possible to safely manufacture breakthrough medicines closer to
where care is delivered and increasing the attractiveness of the
UK as a destination to market new life-saving medicines.”
The legislation proposes a six-month implementation period once
Parliamentary processes have been concluded. This regulation
could, therefore, become law in Summer 2025.
The regulation follows a consultation with
stakeholders in 2021, which showed a high level of support
for proposals for a regulatory framework for point of care and
modular manufacture of medicinal products.
These changes will ensure that our regulations are proportionate,
flexible and adaptable for the implementation of these innovative
manufacturing processes, increasing the attractiveness of the UK
as a destination to market new life-saving medicines.
The MHRA is developing detailed, supporting guidance and will
engage with industry, academia and healthcare institutions to
ensure that the necessary interpretation and procedural support
is in place to support the implementation of the new regulations
ahead of the date that the legislation will come into force.
ENDS
Notes to Editors
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The SI, and associated explanatory memorandum and impact
assessments, are now live on legislation.gov.uk
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This instrument amends the Human Medicines Regulations 2012
(S.I.2012/1916) (“the HMRs”) and the Medicines for Human Use
(Clinical Trials) Regulations 2004 (S.I. 2014/1031) (“the
2004 Regulations”) to provide a new regulatory framework for
medicines manufactured at the point of care, and also for
modular manufacturing, where products are manufactured in
modular, relocatable units.
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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.
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The MHRA announced the introduction of this framework in
January 2023 through this press release.
