Question to the Department of Health and Social Care:

To ask His Majesty's Government what steps they are taking to ensure that more cancer drugs can transition from a Phase 1 study to Medicines and Healthcare products Regulatory Agency (MHRA) approval.

The Medicines and 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 may be reducing the number of cancer drugs that can transition from a Phase 1 study to MHRA approval. To help improve the predictability of decision making in applications for clinical trials, the MHRA have implemented several actions.

The MHRA are looking at novel ways to develop staff capability and expertise. New assessor capacity is being supplemented with an additional fixed-term resource of appropriately experienced and qualified specialists to support the training and supervision of new staff and to help reduce the current backlog. The MHRA has also established links with the Association of the British Pharmaceutical Industry and the BioIndustry Association on clinical trials, to reduce the backlog of delayed applications, which may include applications for cancer drugs. Additionally, they have already reallocated work, and are evaluating queued applications for complexity, to improve the speed of assessment, and are changing processes to take a joined-up risk-proportionate approach.

The MHRA is committed to reducing these backlogs so that it makes regulatory decisions in accordance with statutory timeframes for all new fully compliant clinical trial applications received from 1 September 2023. This will enable more cancer drugs to progress from Phase 1 studies to MHRA approval where appropriate.