New real-world data guidance could accelerate drug approvals

On International Clinical Trials Day 2025, the Medicines and Healthcare products Regulatory Agency (MHRA) has declared there has been “major progress” in the delivery of regulatory framework to make UK clinical trials more efficient and flexible.

“Last month, we began implementing the most significant update to UK clinical trials regulation in over two decades. [Once fully implemented in April 2026, the] reforms will address the research sector’s need for a more risk-proportionate regulatory framework for clinical trials and will help get cutting-edge new treatments to the NHS as quickly as possible,” explained Lawrence Tallon, MHRA Chief Executive.

Tallon highlighted that one in eight UK clinical trials are first-in-human studies.

“The progress the MHRA has made in the two years since I published my review has been remarkable. Despite its global reputation for excellence, by 2023 trial approval set up times had slipped badly. The MHRA is now delivering consistently good approval times while introducing further reforms to add speed and flexibility to the process,” shared Lord O’Shaughnessy, former health minister, senior partner at Newmarket Strategy and author of the report on the UK’s commercial clinical trials landscape.

MHRA’s plans to harness real-world data and build innovative UK clinical trials 

The MHRA has launched a new six-week consultation on the use of real-world data for external control arms of clinical trials. The organisation stated that this could speed up authorisation of medicines. They added that the new guidance is relevant for those planning clinical trials which may include a real-world data external control arm, of which the trial is intended to support regulators with deciding on a medical product.

Access the guideline and take part in the consultation here.