The BMJ has recently noted the Medicines and Healthcare Products Regulatory Agency (MHRA) announcing a new regulatory framework. This aims to make it faster to run (and gain approval for) clinical trials in the UK (Wise, 2023).
The government hopes that the changes will stem the recent (perhaps Brexit-related) decline in clinical research initiated in the UK and cement it as a destination for international trials.
The new framework, which represents the biggest overhaul in UK clinical trials regulation in over 20 years, will integrate regulatory and ethics reviews of clinical trial applications. A pilot scheme showed that this halved the approval time for studies and cut the time from application to recruiting a first patient by 40 days.
The MHRA will also set a maximum time of 30 days for completing an application review, with a maximum of 10 days for a decision.
