Zelluna ASA has received approvals from the U.K.’s Medicines and Healthcare products Regulatory Agency (MHRA) and research ethics committee for its clinical trial application (CTA) for ZI-MA4-1, Zelluna’s lead T-cell receptor-based natural killer (TCR-NK) product candidate.
With CE-marked products accounting for about 90% of medical devices currently used in Great Britain, the Medicines and Healthcare products Regulatory Agency (MHRA) is considering proposals for a path forward that would help the U.K. achieve its goal of becoming a leading country for med-tech access by 2030.
Four years after they were first mooted, the finishing line is in sight for new U.K. clinical regulations, which will come into force on April 28. In the first major update since 2004, about 20% of lower-risk studies are expected to be approved by a fast track, and the Medicines and Healthcare products Regulatory Agency will introduce a 14-day assessment route for phase I healthy volunteer trials, amongst other measures to streamline approvals.
