Press Release; MHRA to streamline clinical trial approvals in biggest overhaul of trial regulation in 20 years

 From the Press Release:

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.

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. 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 decentralised trials.

The press release also notes that among the changes will be a greater collaboration with patient groups. 

A PDF document that summarizes, as well as reviews details on the planned changes can be found here.