Question to the Department of Health and Social Care:

To ask the Secretary of State for Health and Social Care, whether his Department plans to take steps to amend regulations to ensure patients' access to early-phase clinical trials for (a) all diseases and (b) diffuse intrinsic pontine glioma.

The Medicines and Healthcare products Regulatory Agency (MHRA) is introducing new legislation and guidance as part of a swathe of new measures that represent the biggest overhaul in United Kingdom clinical trials regulation in over 20 years.

The agency will introduce more streamlined and efficient application processes, making it easier to apply for trials in the UK, but without compromising on safety standards, including legislating for a combined MHRA/research ethics review. Internationally competitive approval timelines will also be introduced, with more flexibility for sponsors to respond to questions raised by regulators.

These changes will make the UK regulatory environment more attractive for sponsors to bring their trials to the UK, supporting more trials to be run on all kinds of medicines, including treatments for diffuse intrinsic pontine glioma.

The new legislation will help patients access more trials by bolstering the attractiveness of the UK as a destination for innovative and ground-breaking trials of life-saving medicines.