UK clinical trial pilot helps companies prepare for the new EU Clinical Trial Regulation

To prepare for the future of clinical trials under the European Union (EU) Clinical Trial Regulation 536/2014, the United Kingdom (UK) has been running a pilot program which aims to streamline the submission and review process for applications to run Clinical Trials of Investigational Medicinal Products (CTIMPs). So far the pilot has had more than 40 applications.

Since April 2018, the pilot has been jointly run by the UK’s Health Research Authority (HRA) and Medicines and Healthcare products Regulatory Agency (MHRA). Under the pilot, a single CTIMP application can be submitted for the Clinical Trial Authorisation (CTA) and Research Ethics Committee (REC) opinion.

The HRA stated that “the reviews are undertaken independently, but the outcome of the review is co-ordinated to ensure that any requests for further information or changes to documentation are compatible. Applicants receive a single co-ordinated communication to request further information or document changes, and a single communication to confirm the final decision”.

The MHRA expects that the pilot will become a fully-fledged program for all trial sponsors, therefore some sponsors with different departments dealing with CTA and REC submissions may need to make the necessary changes as they will submit one application dossier for both the CTA and the REC.

One of the companies participating in the pilot stated that they have “seen a significant decrease in MHRA and REC approval timelines which has been welcomed by our clients.” A noticeable change compared to the usual approvals service is the 14-day window for updating applications in response to requests for further information from the regulators. The clinical trial pilot is also developing guidance on clinical trial amendments.

To read more about the pilot and how to get involved, please click here.