Clinical Trials: UK regulatory landscape set for change

Introduction

On 12 December 2024, a significant milestone was reached in the evolution of the UK's clinical trial landscape as the Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2024 were laid before Parliament for debate (the “Updated Regulations”). The Updated Regulations are set to amend the UK’s existing regulatory framework, marking a pivotal shift in how clinical trials are conducted in the UK.

With a 12-month implementation period, the Updated Regulations are expected to come into force in January 2026. We set out below some of the key changes contemplated by the Updated Regulations and their potential impact on the clinical trial environment in the UK.

Reform objectives

In reforming the UK’s clinical trial regulatory framework, the Government’s key objectives include the following:

1. Global competitiveness: Positioning the UK as an attractive location for clinical trials, enabling it to compete on a global stage;
2. Regulatory flexibility and proportionality: Introducing a more flexible and proportionate regulatory framework aimed at streamlining processes while promoting patient safety; and
3. Reducing regulatory burden: Easing the overall regulatory burden on trial sponsors, particularly where trials are considered lower risk, to foster efficiency and innovation.

Key proposed changes to the regulatory framework 

Streamlined combined review and approval process

The Updated Regulations streamline approval procedures and align them with the EU’s clinical trial regime by combining the separate applications for Medicines and Healthcare products Regulatory Agency (“MHRA”) and Research Ethics Committee approvals into a single combined review application route. This approach reduces administrative burden for trial sponsors in the hopes of accelerating the initiation of clinical trials and seeks to ensure that statutory timeframes for regulatory assessments are complied with.

The Updated Regulations also include a sunset period on trial approvals whereby an approval will lapse after a period of two years if no participants have been enrolled and no extensions have been granted.

New notification process for lower risk trials

The Updated Regulations will allow for trials deemed to be lower risk, known as “Notifiable Trials” (i.e. those that have no significant safety concerns, do not involve certain vulnerable patients, do not involve advanced or first-in-human therapies and either (a) use an investigational medicinal product that is already authorised in the UK; (b) investigate the same product for the same indication as another trial approved in the UK in the last two years; or (c) have already been approved by a regulatory authority in the EU, an EEA state, or in the US), to go through a more efficient review process which only requires notification to the MHRA (though review and approval from a Research Ethics Committee will still be required).

Additional changes aimed at introducing more proportionate regulation for lower risk trials will be introduced, including a risk-adapted approach for labelling and a simplified process for seeking and recording consent from participants.

New transparency requirements

For the first time, sponsors will be required to register trials in the World Health Organization’s International Clinical Trials Registry Platform, thereby aligning the UK’s regulatory framework with international transparency initiatives. Trial sponsors will also be required to publish a summary (which is understandable to laypersons) of trial results within 12 months of the end of the trial. These new transparency requirements aim to reinforce public trust in clinical research and to enable the wider scientific community to build on previous findings. There will be some exceptions to this – for example, delays to protect confidential information or waivers for national security.

Conclusion

The Updated Regulations bring the UK regulatory framework into closer alignment with the EU clinical trial regime, while introducing greater flexibility and embedding risk proportionality into the process. This reform builds on the UK Government’s broader mission to transform the healthcare system – improving the UK’s ability to attract high-quality clinical trials is expected to contribute to the Government’s objective to create a modern health service designed to foster innovation and deliver worldclass care.

The Updated Regulations will be supplemented by additional guidance developed by the MHRA alongside the Health Research Authority (HRA), which is expected to be published in January 2026 to coincide with the implementation of the Updated Regulations.

Article co-authored by Lexi Stefanatos, Trainee Solicitor at CMS.