The UK will undergo the biggest overhaul of clinical trials law in two decades and replace the current clinical trial legislation, with the aim of making ‘the UK one of the best countries in the world to conduct clinical research for patients and researchers’.
On 28 April 2026, new Clinical Trial Regulations will enter into force which will ‘allow for a more proportionate, streamlined, flexible and effective clinical research environment, putting patients at the heart and the UK at the forefront of innovative regulation for clinical trials’. The updated regulations are designed to protect trial participants, strengthen patient safety, and accelerate approvals by reducing unnecessary burdens on researchers, to support high-quality, trusted research taking place in the UK. Any application for approval of a clinical trial submitted on or after 28 April 2026 will need to follow the new regulation.
Key Regulatory Changes:
The new Regulations foresee a proportionate and flexible approach to regulation introducing several keys changes to how clinical trials are managed in the UK.
Approval Process
The approval process for applications will be simplified and streamlined. The combined review process, introduced in January 2022 leading to a single UK Medicines and Healthcare products Regulatory Agency (MHRA)/ Regional Ethics Committee (REC) decision on the trial, will be embedded into the legislation. The overall timeline for a decision on a trial will be defined as 60 days within the Regulation. The time for the Sponsor to respond to Requests for Further Information (RFIs) is extended to 60 days, recognising that the current timeframe of 14 days raises practical difficulties for Sponsors resolving complex scientific and technical questions.
In addition, a risk-proportionate approach will be used to introduce the concept of ‘notifiable trials’ for lower-risk trials which meet certain inclusion criteria and have no significant safety concerns with any of the Investigational Medicinal Products (IMPs) used. These ‘notifiable trials’ will receive automatic approval from the MHRA and follow an expedited review process from REC.
One notable difference under the Regulation is that trial approval will lapse if no recruitment occurs within 2 years, meaning that Sponsors need to notify the date on which the first participant was recruited to the MHRA.
The aim is to make it quicker and easier to set up and run clinical trials, speeding up research that could lead to new and better treatments for patients.
Transparency
The new Regulations look to promote research transparency and aim to increase public trust in research, which is vital to ethical research practice. In order to do this, registration of a trial in a public register, publication of the summary of results within 12 months of the end of trial and sharing the trial findings with participants becomes mandatory with the new Regulation. It is expected that greater transparency of clinical trial results will help boost participation, inclusion and diversity meaning that patients from all backgrounds will feel that their contributions are having a real effect on developing new treatments, placing them at the centre of medical research.
Good Clinical Practice
The implementation of the latest international Good Clinical Practice (GCP) guidelines (ICH-GCP E6(R3)) will come into force in the UK, with the updated Regulations. ICH-GCP E6(R3) looks to modernise trial standards, integrate technology, and promote risk-based approaches for better patient safety and efficiency and expands the roles and responsibilities of the Sponsor. All trials will need to adhere to the overarching principles of GCP, and trials for Marketing Authorisation will need to comply with the full ICH guidelines.
In addition, the retention period of the Trial Master File (TMF) is extended to 25 years for trials approved under the new Regulations in line with EU CTR.
Safety Reporting and Pharmacovigilance
Safety reporting requirements have been simplified and improved to reduce administrative burden on Sponsors and Investigators without any compromise to patient safety. Safety reports will only need to be sent to the MHRA, rather than both the MHRA and REC, thus removing unnecessary duplication. The requirement to list all Serious Adverse Events (SAEs) and Serious Adverse Reactions (SARs) in annual safety reports is removed. The timeline for written notification of urgent safety measures has been extended from 3 days to 7 days, to allow additional time to gather data that will facilitate the regulatory assessment of the measures. Finally, safety recording and reporting in lower risk trials has been simplified by applying a risk proportionate approach.
Simplified Arrangements for Consent
Sponsors of low-intervention trials using authorised medicines in routine care may use simplified methods for obtaining and recording informed consent.
An advisory group with relevant expertise has been established to develop principles that guide Sponsors and researchers, set Health Research Authority (HRA) expectations to maintain public trust, and support RECs in evaluating the ethical use of simplified consent arrangements.
Amendments to the Trial
In alignment with the EU CTR, changes to clinical trials are redefined under the Regulation as ‘modifications’ and can be categorised as substantial, modifications of an important detail or minor.
Substantial modifications are further categorised based on risk as Route A or B:
- Route A modifications are those likely to have a substantial impact on the safety or rights of the participants or on the reliability or robustness of the data generated in the trial and require a full, standard assessment;
- Route B modifications are those defined in regulation 11B of the Clinical Trial Regulations which do not introduce any significant new safety concerns and are therefore eligible for automatic approval.
Modifications of an important detail do not meet the definition of ‘substantial’, however, the authorities need to be aware of them for administrative or oversight purposes.
Minor modifications are changes that do not significantly impact participant safety or rights and do not change an important trial detail. These may be implemented at any time and without informing the MHRA or REC.
The changes are made to streamline the process and to make safety and regulatory oversight proportionate to risk.
In addition, to help streamline the process further and minimise rejections that may cause delays or interruptions to an ongoing trial, the MHRA and REC can now request further information during the assessment of a substantial modification with the Sponsor having up to 60 days to respond to the request.
Guidance
The MHRA and HRA have both published comprehensive guidance to support Sponsors in preparing for the implementation of the new regulations, however, further updates are expected to the guidance before these come into force on 28 April 2026.
Conclusion
Overall, the new Regulations aim to provide support for greater innovation in clinical trials with the MHRA taking a risk-proportionate approach throughout the clinical trial life cycle and making the UK a more attractive market for clinical trials.
How can S-cubed help you?
S-cubed can prepare and coordinate all the necessary regulatory documentation you may require for a CTIMP or IMP/Device application in the UK, including authoring IMPDs and IBs and ensuring these meet the relevant UK requirements. We can also support the submission of a trial application through to determination, and throughout the life-cycle of the trial.
Any Questions?
If you have any questions on this topic, please don’t hesitate to ask. You can contact us here, via email (info@s-cubed.co.uk), and telephone (S-cubed Ltd: +44 1235 77 22 60).