Quality & Compliance
Safety & Vigilance
25 april 2022
The Clinical Trials Regulation (EU CTR) Regulation EU 536/2014 came into force on January 31, 2022, for all participating European countries. Following the United Kingdom’s (UK) decision to leave the European Union (EU), there are now alternative arrangements for clinical trials conducted in the UK. In this two-part series, we will explore the UK’s new approach, followed by a second article to detail the necessary steps needed for applicants pre-and-post submission.
On January 1, 2022, the UK application process was streamlined into a co-ordinated review process – which includes the opinions from both the Medicines and Healthcare products Regulatory Agency (MHRA) and the Health Research Ethics committee. This provides a single UK decision on applications for Clinical Trial Investigation Medicinal Products (CTIMP). The benefit of this combined review service includes having a single application for the Clinical Trial Authorization (CTA) and Research Ethics Committee (REC) opinion. This streamlined application process has a single channel of communication so both opinions can be delivered together in a new dynamic approach. This also extends to the review and approval of CTA Substantial Amendments.
All CTAs must be submitted to the MHRA using a new part of the Integrated Research Application System, also known as the IRAS. Compared to the old CTA process, applicants must now submit to the REC and MHRA together as there is no longer an option to make separate submissions. The new IRAS portal allows applicants to view or revise their application rather than needing to create a PDF of an in-progress application. This may impact an applicant’s current review process. In addition, correspondence such as requests for further information or final outcomes will now only be sent to specific sets of contacts, meaning that organizations will need effective internal communication channels in place.
The Future of Clinical Trials in the UK:
Earlier this year, on January 17, the MHRA launched an open consultation; the consultation enables researchers, developers, and sponsors to contribute their views to positively transform UK clinical trials. The MHRA aims to:
The consultation closed on March 14; the feedback from the consultation will be made public later in the year.
In the meantime, it is vital that healthcare organizations and manufacturers are aware of the steps they need to take when planning clinical trials in the UK. The next article will detail the registration and application process for the CTA system, including details of the assessment deadlines, and potential outcomes. If you have any questions on the UK and European clinical trials application process, and would like to speak to one of our experts, please contact us to learn more about our services and how we can help you prepare your clinical trial applications.
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