Intended for healthcare professionals


Clinical trials: Streamlined framework aims to boost UK research

BMJ 2023; 380 doi: (Published 23 March 2023) Cite this as: BMJ 2023;380:p696
  1. Jacqui Wise
  1. Kent

The Medicines and Healthcare Products Regulatory Agency (MHRA) has announced a new regulatory framework that aims to make it faster and easier to gain approval and to run clinical trials in the UK.1

The government hopes that the changes will stem the recent 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 …

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