UK Clinical Trial Pilot Helps Companies Prep for New EU Regulation

Regulatory NewsRegulatory News
| 20 May 2019 | By Zachary Brennan 

In preparation for the future of clinical trials under EU Clinical Trial Regulation 536/2014, the UK has been running a pilot program for a little more than a year to streamline the submission and review process for applications to run Clinical Trials of Investigational Medicinal Products (CTIMPs).

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

“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,” HRA said.

The pilot has so far dealt with more than 40 applications.

And as the pilot morphs into a fully fledged program for all trial sponsors, which MHRA said Monday is expected, some sponsors with different departments dealing with CTA and REC submissions may need to make changes as they submit one application dossier for both the CTA and the REC.

“Overall we have seen a significant decrease in MHRA and REC approval timelines which has been welcomed by our clients; the pilot process was straightforward and fitted well into PRA’s established processes,” PRA Health Sciences, a contract research organization and participant in the pilot, said. “One change to the usual approvals service is the 14-day window for updating applications in response to requests for further information from the regulators. The pilot is also developing guidance around clinical trial amendments, which will be important if the combined approval system is launched.”

To find out more about the pilot and how to get involved please see the guidance on the HRA website (see link below) or email and include ‘combined ways of working pilot’ in the subject line, HRA said.

The combined ways of working pilot


© 2022 Regulatory Affairs Professionals Society.

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