UK – UK Clinical Trial Pilot Helps Companies Prep for New EU Regulation

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…