Question to the Department of Health and Social Care:

To ask the Secretary of State for Health and Social Care, what steps his Department is taking to ensure the Medicines and Healthcare products Regulatory Agency meets its statutory obligation to assess clinical trials within 60 days of notification.

The Medicines and Healthcare products Regulatory Agency (MHRA) is committed to making regulatory decisions in accordance with statutory timeframes. The MHRA has recently undertaken a significant recruitment exercise to bring on board new specialist staff to increase clinical trial assessor capacity within the Agency. The MHRA are supplementing this new assessor capacity with additional fixed-term resource of appropriately experienced and qualified specialists to support the training and supervision of new staff.

The MHRA continue to develop plans to increase staff capability and expertise, and to review internal processes for efficiencies. To that end, significant progress has been made to draft proposals for how a risk-proportionate approach to clinical trial assessments could be implemented.

Following public consultation, the MHRA plans to reform national legislation to deliver a world-class sovereign regulatory environment for clinical trials that will support the development of innovative medicines and ensure that the UK retains and grows its reputation as a world leading base for life sciences.