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.
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The MHRA is an executive agency of the Department of Health and Social Care.
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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.
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