Question to the Department of Health and Social Care:

To ask the Secretary of State for Health and Social Care, whether the Medicines and Healthcare products Regulatory Agency plans to adapt its regulatory framework for innovative medicines.

The Medicines and Healthcare products Regulatory Agency (MHRA) is transforming its regulatory model to better support innovative medicines while maintaining world-class standards of safety and efficacy.

The agency is developing a more agile and proportionate approach and is creating new regulatory frameworks and specific guidance in response to innovative product horizon scanning and our knowledge of the product pipeline.

For instance, the MHRA have recently consulted on regulatory guidance for individualised mRNA cancer immunotherapies, colloquially referred to as cancer vaccines. The draft MHRA guidance aims to clarify and streamline pathways for bringing these therapies through to patients, without compromising on robust safety principles. This is an important step in bringing these promising therapies closer to clinical practice.

In addition, the MHRA updated the requirements to better improve clarity and transparency on 3 April 2025 for all National Licence Submissions. In July 2025, the United Kingdom will be the first country to introduce a tailored framework for the regulation of innovative products manufactured at the point where a patient receives care, following work from the MHRA that means new medicines with very short shelf lives and highly personalised medicines can more easily be made in or near a hospital setting or ambulance and can get to the patients who need them much more quickly.

This work supports the UK’s ambition to be one of the most attractive places globally to develop, trial, and launch innovative treatments.