On 27 May 2014, the Clinical Trials Regulation was published in the Official Journal of the EU (OJEU).
The regulation, which will replace the existing EU Clinical Trials Directive, will streamline the authorisation process and harmonise requirements for clinical trials in Europe.
Applicants will now submit a single application for a clinical trial, regardless of the number of participating member states and there will be one application per member state.
In the UK, this will mean that a single decision on a clinical trial will replace the current separate approvals given by the Medicines and Healthcare products Regulatory Agency (MHRA) and the Research Ethics Committee (REC).
It will apply from 28 May 2016 unless the IT infrastructure that underpins the regulation is not fully functional, which will result in a delay.
The Health Research Authority (HRA), which is responsible for REC with the UK Health Departments’ Research Ethics Service, and MHRA have been working closely together throughout the negotiations for the regulation and will continue to do so as the UK prepares to implement it.
Recently announced plans for HRA assessment and approval will be a key element in UK preparations for the regulation.