While the US Food and Drug Administration has been experiencing recent reorganization and cuts in personnel, the United Kingdom has its own upcoming policy changes making it easier and faster to initiate and maintain UK clinical trials, which will create attractive new options and strategy decisions for pharma research and development companies.
Background
The departure of the United Kingdom from the European Union in January 2020 has meant that conducting clinical trials in both the EU and UK requires compliance with two sets of regulations. This potentially impacts the UK’s attractiveness in this sector. Moreover, the date the UK left the EU preceded the implementation of the EU Clinical Trials Regulation 536/2014 (CTR), which came into force two years later and introduced a central database of EU clinical trials and a mechanism allowing more streamlined cross-border trials within the EU.
To address this perceived impact, with statistics also showing that patient recruitment had declined, the UK government appointed James O’Shaughnessy, a former health minister, to lead a review of the state of commercial clinical trials in the country. The UK government then embarked on a public consultation, with the response being published in March 2023.
The UK Medicines and Healthcare products Regulatory Agency (MHRA) acknowledged the need for “more proportionate regulatory requirements” in order to gain a “competitive advantage, encouraging sponsors to run trials in the UK.”
The New UK Clinical Trial Regulations
Accordingly, new UK clinical trials draft legislation, Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2024 (the UK Regulations), was introduced in December 2024 and became law on April 10, 2025.
The regulation’s aim is to put participants firmly at the center of how trials are run while supporting faster, more streamlined approvals that make it easier to test new treatments in the UK. The regulation replaces the preexisting UK clinical trial legislation, which was based on the old EU Clinical Trials Directive 2001/20 EC.
It seems the general aim of the new legislation is broadly to align UK law with the CTR but also introduce some UK simplification measures designed to streamline regulations and avoid delays.
The new UK Regulations will do the following:
- Bring into law the combined review process introduced in practice in January 2022 providing for parallel MHRA and ethics committee trial review. The new process folds separate applications for MHRA and Research Ethics Committee approvals into a single combined review application route with a view toward accelerating the initiation of clinical trials and seeking to ensure that statutory timeframes for regulatory assessments are met.
- Simplify the regulation of lower risk clinical trials or “notifiable trials” (for instance, where the risk to participants is similar to standard medical care), trials involving medicines that have already been approved and therefore pose minimal risk to participants, and trials that have been approved in the EU or United States, whereby such trials would only need to be notified rather than approved by the MHRA. However, independent ethics committee approval would still be required with such trials.
- Introduce a legal requirement to register clinical trials in a World Health Organization–recognized public register and publish a summary of results within 12 months of the end of the trial (with the possibility of a deferral to protect commercially confidential information).
- Implement a timeline for completion of an application review within a maximum 30 days in general, up to 60 days for the applicant to respond to questions, and a maximum of 10 calendar days for a decision to be granted once the MHRA has received any final information.
- Introduce more proportionate safety reporting requirements that are not duplicative and do not enhance patient safety monitoring.
- Provide that the approval would lapse after 24 months if there are no participants recruited to take part in the trial.
- Require that non-investigational medicinal products are manufactured in accordance with good manufacturing practice and meet certain labeling and other safety requirements.
In addition to seeking to align with current EU rules, there are a few tweaks that are intended to make the UK especially attractive to drug developers with approval timelines and flexibilities aimed at optimizing international competitiveness. For instance, comprehensive guidance will be used for specific details rather than granular and duplicative requirements in legislation, and the UK has adopted a more flexible approach to low-risk clinical trials than the EU.
Significantly, bearing in mind that transparency is a key focus of changes introduced in the EU under the CTR, the UK may be responding to consensus from the research-based industry that the UK Regulations have not gone as far as the EU legislation in requiring trial transparency. While there has been some discussion of the UK joining the EU Clinical Trials Information System platform, this is not set out in the new UK Regulations.
Additionally, while compliance with the overarching principles of the International Council for Harmonisation Good Clinical Practice guidelines is required, compliance with the entirety of the guidelines will not become a legal requirement in the UK. However, this arguably may be an illusory benefit in that such compliance may still be necessary if the data generated from the trial will be used in other countries.
With the UK Regulations now signed into law, a 12-month implementation period has begun before the UK Regulations come fully into force on April 10, 2026.
Looking Ahead
It seems clear that the UK government is prioritizing enhancing the attractiveness of the UK for clinical trials. The UK Regulations are part of a plan announced by the UK government earlier this year to “turbocharge” medical research in the UK with a goal of reducing the time it takes for trials to commence from 250 days post-application to 150 days. There has been substantial focus on the MHRA post-Brexit approval times generally, including for clinical trials, and any shortening of published and actual timelines will be welcomed by industry.
In addition to speeding up clinical trials, the government and the London-based nonprofit Wellcome Trust are investing some £600 million (approximately $797 million) to create a new health data research service meant to improve researcher access to NHS data. Consolidating access to data for medical research in one location, Wellcome’s Genome Campus in Cambridgeshire, avoids researchers needing to make multiple applications for information for the same project.
Wes Streeting, the UK government health secretary, said that the innovation was introduced with a view to improve accessibility to “the unparalleled power of NHS data” to “drive vital investment into the UK and put us at the epicentre of breakthroughs in science.”