Question to the Department of Health and Social Care:

To ask the Secretary of State for Health and Social Care, what discussions he has had with the MHRA on the potential impact of regulatory reform on the time taken to develop glioblastoma treatments.

The Medicines and Healthcare Products Regulatory Agency (MHRA) is an executive agency of the Department and regulates medicine, medical devices, and blood components for transfusion in the United Kingdom, with responsibility for ensuring medicines meet appropriate standards of safety, quality, and efficacy.

The impact of the new regulatory reform on the development of glioblastoma is that the new regulations will introduce notifiable trials, including initial and modification trials, which will be approved within 21 days without further assessment if they meet the inclusion criteria. Therefore, these submissions will be approved with a short turnaround time. This approach will free up assessors’ time to provide more support for trials that require closer scrutiny. The trials in glioblastoma are part of the oncology area, which represents almost 30% of all submissions received by the MHRA.