Major Reform of UK Clinical Trials Regulation

The response to the consultation on reforming the UK clinical trials regulation has been published. According to the press release, a series of new measures will be introduced by the UK Medicines and Healthcare products Regulatory Agency (MHRA).

New Framework

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 Clinical Trials Directive (CTD) to make if faster and easier to gain approval and to run clinical trials in the UK.

"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." Changes include implementing a maximum of 30 days for completing an application, with 10 days for the assessor to make a decision, and an integration of the regulatory and ethics reviews for applications.

According to the agency, the legislative changes will result in a regulatory framework that is as future-proof as possible, responsive to different types of trials and innovative designs, and supportive of new ways of carrying out trials such as decentralized trials.

For more information please see the press release MHRA to streamline clinical trial approvals in biggest overhaul of trial regulation in 20 years.