Sponsors can expect to see a copy of final guidance on how to comply with the UK’s new clinical trials regulation in August 2025, while the new framework is set to apply from January 2026.
The UK government has approved plans from the Medicines and Healthcare products Regulatory Agency to move forward with its clinical trials framework reform.
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Sponsors and regulatory agencies within the 27 EU member states must all be “committed” to working with the EU Clinical Trials Regulation in the most appropriate way to keep pace with other countries, including the UK where competition is heating up, says Miguel Forte, CEO of Kiji Therapeutics.
Study sponsors looking for guidance on how the simplified informed consent provisions will be implemented under the new UK clinical trials legislation will have to wait longer. The Health Research Authority is looking at what safeguards are needed to address the “range of concerns” stakeholders had regarding its initial proposal.
A first-of-its-kind review of clinical trial applications submitted to the UK medicines regulator, the MHRA, shows there is a concentration of research in certain disease areas and identifies opportunities to enhance the representation of specific patient groups.
Faced with Trump’s hostile tariff moves, the UK aims to speed up clinical trial start times to support its pharma sector and invest £600m in a new health data research service.
Several critical FDA drug activities can skirt early Trump administration directives, but trial diversity and health equity work may be hobbled.
A six-year project aiming to establish a “less fragmented and more democratic” approach to clinical studies has commenced in the EU.
The draft guidance clarifies that sex and gender are not interchangeable, but could be vulnerable in the Trump Administration as Republicans have argued against transgender medical care and that sex and gender must be congruent.
