The UK has taken a massive step forward in the holy grail of personalised medicine by introducing new regulations that enable treatments to be prepared and delivered directly at the point of care.  The Human Medicines (Amendment) (Modular Manufacture and Point of Care) Regulations 2025 positions the UK as a global leader in decentralised healthcare innovation, tying in with key drivers in the recently published Life Sciences Sector Plan and NHS 10 Year Health Plan - notably, enabling people to be treated closer to home and the MHRA acting as a world-leading brand in leading on agile and proportionate regulation.

What Does This Mean for Patients?

• Patients will now have access to life-saving treatments such as CAR-T cancer therapies and gene therapies within days, rather than waiting weeks or months for manufacturing at distant facilities. 
• Highly specific therapies, including those with very short shelf lives, can now be prepared and administered on-site at hospitals, clinics, or even at home.  This is instead of medicines being unable to be delivered due to their limited shelf life. 
• This shift will reduce waiting times, free up NHS beds, and ensure that treatments reach patients when every hour matters.
• For example, cancer patients could have their immune cells collected, modified to fight their specific cancer, and returned - all within just days not months.  Or a young person with a rare genetic condition could have a freshly prepared therapy with only minutes of shelf life, made and given there and then.

Key Features of the Legislation

• The framework allows hospitals and local care settings to perform the final manufacturing steps of personalised treatments, under strict regulatory protocols.
• Mobile manufacturing units will enable care to be delivered closer to home - benefiting patients who are too unwell to travel or are immunocompromised.
• Clear guidance and oversight will be provided by central control sites, ensuring safety and consistency.

Enhancing the UK's reputation as a leader in cell and gene therapy

Hertfordshire is home to the third biggest cell and gene therapy cluster in the world and the biggest outside of the US.  Matthew Durdy, Chief Executive of the Cell and Gene Therapy Catapult in Stevenage, hailed this change, which “demonstrates how the MHRA is leading in the UK’s commitment to being at the forefront of modern healthcare, innovation and regulation. The MHRA has recognised that some practices are better with more flexibility, and that in a technology enabled world which allows better training, information and communication, flexibility can be enabled without compromising safety.  This is not just a step forward for innovative medicines such as cell and gene therapies, it is a step towards enabling truly personalised medicine.”

Looking Ahead

These new regulations not only revolutionise patient care but also underscore the UK's commitment to leveraging innovation for better health outcomes.

As personalised medicine becomes more engrained, patients in the UK can look forward to a future where cutting-edge treatments are more accessible, timely, and effective - whilst the pharmaceuticals and life sciences industry can be part of this exciting future.

Are you in the cell and gene therapy or personalised medicine space?  What do you think of the opportunities coming from this change?  I'd be interested to hear any thoughts you have on these developments and how they may affect you?  Do contact me on pgershlick@vwv.co.uk