PARLIAMENTARY WRITTEN QUESTION
(21 November 2025)

The Medicines and Healthcare products Regulatory Agency (MHRA) has completed a public consultation on its draft guideline on individualised mRNA cancer immunotherapies, a new type of personalised cancer treatment. These technologies use cutting-edge science such as artificial intelligence to design a medicine tailored to each patient’s unique tumour profile.

We received positive responses from across the life sciences community, the National Health Service, patient groups, academics, and international regulators. Feedback recognised the United Kingdom’s leadership in this area, while calling for greater clarity in some aspects of the guideline.

In response, we will refine the guideline to ensure regulatory expectations are clearly articulated, without hampering innovation. This will facilitate faster access to these promising new therapies, while upholding our standards of safety, quality, and efficacy. The final version of the guideline will be published in the coming months, with future updates anticipated as the regulatory experience evolves in this rapidly developing field.