New regulations governing clinical trials in the UK came into force today, the Medicines and Healthcare products Regulatory Agency (MHRA) and Health Research Authority (HRA) said, following a consultation with patients, researchers, doctors, and industry. For the first time, registration of trials and publication of summary results will be a legal requirement.

The regulations introduce faster assessment of first-in-human trials, the introduction of notifiable trials, a fast-track route to allow lower-risk trials to start sooner, and a new pathway offering a faster, risk-proportionate way to assess substantial modifications that do not introduce new safety concerns.

The reforms will also allow consideration of early safety data from suitable overseas studies, and computer model simulations to predict how new drugs may behave before they are tested in patients. A new combined review process aligning the MHRA and research ethics committees will enable researchers to apply for ethics and regulatory approval in one go to speed approvals of applications and substantial modifications.

Clinical Trial Set-Up Times Cut by a Quarter

The MHRA and HRA said they had already exceeded the government's target of reducing clinical trial set-up times to 150 days. According to the regulators, times have fallen from 169 to 122 days for commercial trials over the past year — a reduction of more than a quarter.

The combined safety and ethical review conducted by both bodies now takes an average of 41 days, less than half the time it took several years ago. Dr Zubir Ahmed, health innovation and safety minister, said the improvements meant patients would access new treatments sooner, while reinforcing the UK's position as "one of the most attractive places in the world to invest in cutting-edge research."

According to a report commissioned by the Association of the British Pharmaceutical Industry, in 2022 industry clinical trials generated £7.4 billion for the UK economy, including £1.2 billion revenue going to the NHS, and supported 65,000 jobs, including 13,000 in the NHS.

Bureaucracy Cut, Sponsors Get New Guidance

The Department of Health and Social Care said a £137 million investment in health research reforms had enabled the streamlining of processes, with trials that previously took close to a year to start now set up in a matter of months. Patients could access new treatments sooner, it said, "without waiting years while administrative processes catch up with the science."

Contract research organisation Linical described the reforms as embedding a “risk-proportionate approach,” meaning that regulatory oversight will better reflect the level of risk involved in a trial. Krzysztof Majkowski, Linical's associate director of regulatory affairs, said last month that the reform marked “a decisive shift” away from the current framework, which was based on 2004 legislation.

Higher-risk studies will continue to receive intensive scrutiny, while lower-risk trials will benefit from lighter, more streamlined requirements, he said. 

The MHRA's clinical trials hub provides practical guidance for sponsors on applying the new legal framework under the Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025.

Dr Sheena Meredith is an established medical writer, editor, and consultant in healthcare communications, with extensive experience writing for medical professionals and the general public. She is qualified in medicine and in law and medical ethics.