To ask the Secretary of State for Health and Social Care, whether the Medicines and Healthcare products Regulatory Agency expedites human challenge trial applications where a case has gone beyond its 60-day review deadline.
Answered on
5 July 2023
The Medicines and Healthcare product Regulatory Agency (MHRA) is dealing with queued applications sequentially. However, the MHRA is reallocating work and routinely evaluates applications for their complexity and prioritises applications based on public health impact, patient safety and patient need. This approach applies to all queued clinical trials including human challenge trial applications that have exceeded the 60-day review deadline.
Answered by
Department of Health and Social Care