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Guidance on decentralised, or point-of care (POC), medicines manufacture has been published by the Medicines and Healthcare Regulatory Agency (MHRA), in what the body said is a world first.
In its overview of the guidance, published on 10 June 2025, the MHRA said: “The new regulatory framework supports increased manufacture and supply of new medicinal products manufactured at POC, whilst ensuring that they retain equivalent levels of safety, quality and efficacy currently in place for medicinal products manufactured in factory-based locations.“
The framework will be used in the manufacture of medicines with a short shelf-life, or highly personalised medicines, at sites within or close to a hospital, according to the document.
It also covers ‘modular manufacturing’, in which medicines are manufactured in portable manufacturing units — for example, for use in the deployment of vaccines during a pandemic.
Plans for the guidelines were announced by the MHRA in October 2024.
At the time, Ian Rees, POC lead at the MHRA, said the framework would be “the first of its kind in the world”.
POC medicines include some types of advanced therapy medicinal products, 3D printed products that can only be printed at POC, blood products and medical gases, the MHRA said.
The guidance was developed in response to the Human Medicines (Amendment) (Modular Manufacture and Point of Care) Regulations 2024, which is an amendment to the Human Medicines Regulations 2012 and the Medicines for Human Use (Clinical Trials) Regulations 2004.
The amendment became UK law on 23 January 2025 and comes into effect on 23 July 2025.
Speaking in a House of Commons debate on 27 November 2024, health minister Karin Smyth said that the framework was “brought forward pre-emptively to encourage increased manufacture and supply of innovative medicines that can only be manufactured at or close to the POC or by modular manufacturing”.
A spokesperson for the MHRA told The Pharmaceutical Journal: “The introduction of this novel regulatory framework will drive tangible benefits for patients, allowing easier access to a greater and more personalised range of treatments for those in need, while ensuring the highest standards of quality, safety and efficacy are maintained.
“The framework, and associated guidance, is the first of its kind in the world and will make it possible to safely manufacture breakthrough medicines — including those with very short shelf-lives or highly personalised treatment options — closer to where care is being delivered, while also increasing the attractiveness of the UK as a destination to market new life-saving medicines.”
Claire Anderson, president of the Royal Pharmaceutical Society, said: “The MHRA’s guidance is a welcome step towards making personalised, POC treatments a reality, helping patients receive the medicines they need efficiently and safely. Pharmacists will be key in delivering these treatments closer to where a patient may be receiving care.
“Robust regulation, workforce training and investment in facilities will be vital to support safe implementation and to help realise the potential of hospital-at-home services and virtual wards, relieving pressures on hospitals.”
