A series of new measures will be introduced by the Medicines and Healthcare products Regulatory Agency (MHRA) with support from partners to make it faster and easier to gain approval and to run clinical trials in the UK. These changes represent the biggest overhaul in UK clinical trials regulation in over 20 years and will help to make the UK one of the best countries in the world to conduct clinical research for patients and researchers.
Under the new framework, clinical trials application processes in the UK will be more proportionate, streamlined and flexible without compromising on safety, helping to cement the UK as an attractive destination for trials, including global “multi-site” trials. For example, the integration of the regulatory and ethics reviews of clinical trial applications, which in pilot phase halved the approval times for studies and cut the time from application to recruiting a first patient by 40 days, will be embedded into the new regulation…
