New U.K. clinical trials regulations coming into force today, April 28, aim to reduce the time taken to get approval for studies and introduce a category of lower risk trials which will be automatically assessed in 14 days. The key measure to cut timelines is the Combined Review, under which sponsors will be able to submit a single application for regulatory review by the Medicines and Healthcare products Regulatory Agency and ethics review by the Health Research Authority, the body responsible for managing ethics committees.
Wegovy (semaglutide) has passed the notoriously strict cost-effectiveness scrutiny of the U.K. health technology assessment body and will now be reimbursed for the prevention of further serious cardiovascular events in people who have had a heart attack or stroke, or are diagnosed with peripheral arterial disease.
The U.K. Medicines and Healthcare products Regulatory Agency (MHRA) is to offer an early review of nonanimal data to give companies more confidence that evidence generated with new approach methodologies, such as organoids and microphysiological systems, will be accepted as part of marketing authorization applications.
U.K. biopharma is working with the country’s space agency and Civil Aviation Authority (CAA) to plot a route for manufacturing biologic drugs in low earth orbit.
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.
The U.K. Medicines and Health Care Products Regulatory Agency provided an update of its guidance for clinical investigations for medical devices and is offering a temporary waiver of the fees for registration of clinical studies to small manufacturers.
The Trump administration has made known that it intends to foster rapid adoption of AI, starting with a repeal of an executive order (EO) issued by the Biden administration. Now, the White House has issued an EO that would override state AI law, a move that addresses a task that Congress to date has failed to complete.
Zelluna ASA has submitted a clinical trial application (CTA) to the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) for ZI-MA4-1 (ZIMA-101), the company’s lead candidate. ZI-MA4-1 is a novel MAGE-A4-targeting T-cell receptor-natural killer (TCR-NK) therapy.
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