Question to the Department of Health and Social Care:

To ask the Secretary of State for Health and Social Care, what steps the Medicines and Healthcare products Regulatory Agency is taking to reduce the time it takes to assess human challenge clinical trials.

The Medicines Healthcare products Regulatory Agency (MHRA) is aware that customers who have submitted initial applications and amendments to our Clinical Investigations and Trials team have experienced extended timeframes in some cases and understands how this unpredictability is impacting companies. The MHRA has taken several significant steps to address the extended timeframes for clinical trial approvals. This includes, but is not limited to, prioritising recruitment and training of specialist staff, working with external stakeholders to streamline and improve its processes, and enhancing customer service support and communications. The MHRA regularly reviews and prioritises applications based on public health impact, patient safety and patient need. Unless a human challenge trial application is considered to meet those criteria it is not prioritised over other clinical trial applications.