The UK Government has passed a new legislation, allowing personalised medicines to be manufactured at the point of care — where patients are treated.

The Human Medicines (Amendment) (Modular Manufacture and Point of Care) Regulations 2025, which came into effect on 23 July, positions the UK as the first country in the world to establish a dedicated legal framework for on-site medicine manufacturing.

Introduced by the Medicines and Healthcare products Regulatory Agency (MHRA), the framework covers a broad range of innovative products, including cell and gene therapies, tissue-engineered treatments, 3D printed products, blood products, and medicinal gases.

The new law is expected to accelerate research, clinical trials, and patient access to cutting-edge treatments while strengthening the UK’s leadership in safe, decentralised manufacturing.  

“This world-first legislation is a game-changer for patients. Cancer treatments tailored in days, not months. Life-saving therapies made at your bedside, not hundreds of miles away,” said UK Health Secretary Wes Streeting.

“We are turning around our NHS with waiting lists at their lowest for two years - this type of therapy means patients can be treated and return home more quickly,” he added.

The MHRA is also working internationally to support similar changes in other countries. Recently, it played a key role in the first global workshop on point-of-care manufacturing, through the International Coalition of Medicines Regulatory Authorities (ICMRA).

MHRA Chief Executive Lawrence Tallon called the new legislation a “landmark moment.”

He said, “Patients will now receive highly personalised treatments more quickly and nearer to their bedside, with the same rigorous standards as all medicines.”

“It’s a landmark moment that opens the door to a future where highly personalised treatment – made for one person, in one place, at one time – becomes part of routine care.”

“The UK is leading the world in this next generation of medical innovation, and as the UK regulator for medicines and medical devices, we’re determined to play our role in providing the supportive regulatory framework to help our health partners and medicines innovators bring can bring these new treatments to patients,” he added.

The new legislation is part of the UK government’s 10-Year Health Plan, announced by Prime Minister Keir Starmer on 2 July.