The long-awaited Government response to the consultation on reforming clinical trials regulation has been published. The changes represent the biggest shift in clinical trial regulation in 20 years. The MHRA say they will “help to make the UK one of the best countries in the world to conduct clinical research for patients and researchers”.
Broadly speaking, the proposals focus on trying to make the UK an attractive destination for clinical trials, by reforming a regulatory regime which is still based on the 2001 EU Directive to make if faster and easier to gain approval and to run clinical trials in the UK.
While the MHRA played a key role in shaping the EU’s new Clinical Trials Regulation, the timing of Brexit meant that the new EU regime was never implemented in the UK, leaving the UK with a framework based on law that was generally accepted to be in need of an overhaul.
Changes include implementing a maximum 30 days for completing an application (subject to some exceptions), with 10 days for the regulator to make a decision once it has received all information, and an integration of the regulatory and ethics reviews for applications, which has been shown to significantly reduce the time from application to recruiting patients.
There are a large number of proposed reforms. We have summarised these in the table below and the full response can be read here.
The legislative changes will help to make the UK one of the best countries in the world to conduct clinical research for patients and researchers - MHRA
