A series of new measures will be introduced by the MHRA to make it faster and easier to gain approval and to run clinical trials in the UK.
The MHRA said the changes represent the biggest overhaul in UK clinical trials regulation in over 20 years – making the UK one of the best countries in the world to conduct clinical research.
The changes follow a public consultation. 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.
The MHRA will also implement a timeline for completion of an application review within a maximum 30 days in general, with a maximum 10 calendar days for a decision to be granted once the regulator has received any final information.
On transparency, the framework will introduce a legal mandate to register the trial in a World Health Organisation (WHO) public register, and a requirement to publish a summary of results within 12 months of the end of the trial. Sharing trial findings with participants in a timely manner and suitable format will also be required by law.
Comprehensive new guidance will be introduced to accompany the new measures. This will ensure that UK clinical trials truly work in partnership with patients and the public and are representative of the diversity of people who may benefit from the medicine if the data generated ultimately lead to regulatory approval.
Read more on the MHRA website.
