New UK Clinical Trial regulations to take effect from 28 April 2026

The UK’s updated Clinical Trial Regulations and Good Clinical Practice (GCP) standards will officially come into force on 28 April 2026, marking a major milestone in the transformation of clinical research regulation. 

The changes are designed to enhance patient safety, streamline trial approvals, and strengthen the UK’s position as a global leader in life sciences and innovation.

The Health Research Authority (HRA) has published detailed guidance to support organisations in understanding and applying the new regulations. While the Medicines and Healthcare products Regulatory Agency (MHRA) has not yet released its final guidance, draft materials are available and can be used to inform early preparations.

During this transition period, the MHRA will continue to inspect organisations against the current UK Clinical Trial Regulations and GCP standards. However, inspectors may also assess how organisations are preparing for the upcoming changes, offering an opportunity to demonstrate proactive compliance.

Catherine Johnston, Training Manager at Health and Care Research Wales, said: “With the implementation period now underway, research teams across the UK are being encouraged to begin preparing for the new framework. 

“This includes reviewing internal processes, updating standard operating procedures (SOPs), and engaging with training and information events to ensure readiness ahead of the deadline, which we can help with here at Health and Care Research Wales.”

A significant part of the transition involves updates to GCP training. The National Institute for Health and Care Research (NIHR), which manages the GCP training suite, is currently working in partnership with stakeholders to revise the training materials in line with the new regulations. 

Staff whose roles require a GCP certificate will be expected to complete the updated training once it becomes available.

The revised training is expected to launch by January 2026, giving staff time to complete it before the April deadline. It will be offered in a range of formats, including eLearning, live virtual sessions, and face-to-face training.

In response to user feedback, a new facilitator-delivered GCP Refresher course will also be introduced, providing an alternative to online-only learning.

Dr Nicola Williams, National Director of Support and Delivery at Health and Care Research Wales, said: 

“The new regulations will help us deliver more efficient, inclusive, and patient-centred trials. We’re committed to supporting our research community through this transition and ensuring everyone has the tools and training they need to respond.”

For more information on this, watch our Faculty webinar - Forthcoming changes to clinical trial legislation and approvals processes with Cat Johnston and Gurmel Bhachu

FAQs

What is GCP?

Good Clinical Practice is a set of internationally recognised ethical and scientific quality standards for designing, conducting, recording, and reporting clinical trials that involve human participants. It ensures the rights, safety, and well-being of participants are protected while also ensuring the reliability and credibility of trial data. GCP is a requirement for drug studies and is considered best practice for non-drug studies.

What is the difference between GCP and the UK Clinical Trial Regulations?

GCP is the international standard for conducting clinical trials. The UK Clinical Trial Regulations set out the legal requirements in the UK for how to run clinical trials, the GCP principles are embedded within those regulations.

Why are the UK Clinical Trial Regulations being updated?

The new regulations introduce a clear and consistent framework for how clinical trials are conducted in the UK. These updates reflect a shift away from the traditional ‘one size fits all’ model, promoting greater flexibility and proportionality to better support diverse research needs. The new regulations will help to:

• Ensure we include all participants and promote the inclusion of underserved populations in clinical trials, aiming to increase diversity
• Ensure patients and their safety are at the focus of all clinical trials and bring the benefits of clinical trials to everyone.
• Create a proportionate and flexible regulatory environment​
• Cement the UK as a destination for international trials​
• Provide a framework which is streamlined, agile and responsive to innovation

When are the new Clinical Trial Regulations and updated GCP guidance coming into force?

The new GCP guidelines, known as ICH E6(R3), will be coming into force in the UK at the same time as the new UK Clinical Trial Regulations, on 28th April 2026. Different countries are adopting the new GCP guidelines on different dates.

What do I need to do in this implementation period?

The UK Clinical Trial Regulations were signed into law on 28th April 2025 and we are currently in a 12-month implementation period before the regulations will be in full force on 28th April 2026. The updated GCP guidelines will also be adopted on this date. It is recommended that researchers and their teams use this implementation period to prepare for the change. This can include attending training and information events, reviewing internal documents and processes, reading the new regulations and GCP guidelines and meeting with sponsors and teams to ensure a consistent approach to compliance.

My sponsor has asked me why I’m not working towards the new GCP guidelines yet, what should I say?

In the UK, we are currently working to ICH GCP E6(R2) and will not be adopting the updated E6(R3) until 28th April 2026, alongside the new UK Clinical Trial Regulations. However, globally, countries are adopting E6(R3) at different times and this is causing some queries between sponsors and sites in different countries. It is advisable to inform your sponsor of the current position in the UK and to work together to ensure consistent compliance to the study protocol. An official response from the NIHR on the current UK position is written below for your information:

“At present the UK continues to recognise ICH GCP E6(R2) as the applicable standard under the UK Clinical Trials Regulations - The Medicines for Human Use (Clinical Trials) Regulations 2004 (as amended). While the ICH GCP E6(R3) guideline has been finalised the implementation date is up to each ICH member to determine. As you may be aware the UK is in the process of updating its own national legislation (to implement Statutory Instrument 2025/538) and has made the decision to implement ICH E6(R3) at the same time as the revision to our legislation to minimise disruption and multiple revisions to systems and processes within a short space of time. The implementation date for ICH E6(R3) and the revision to The Medicines for Human Use (Clinical Trials) Regulations will come into effect on 28 April 2026 prior to this it is expected that ICHE6(R2) is followed but that work commences to prepare for the implementation date”.

Will these changes affect the approvals process?

Yes, as part of the update to the UK Clinical Trial Regulations there will be changes to study approvals processes and timelines. This includes changes to the amendment process (to be known as modifications) the and way in which MHRA and REC request modifications post-approval For more information visit The approvals process for clinical trials - Health Research Authority

Will these changes affect non- drug (CTIMP) studies? 

The intention is to apply the same processes and timelines across all research applications (to streamline processing, single and consistent requirement (rather than multiple processes) across all application types. 

Are there any changes to terminology?

Yes, the new GCP guidelines and the updated Clinical Trial Regulations have both adopted some new terminology. 

• Subject is now referred to as participants
• Trial site is now referred to as trial location
• Amendment is now referred to as modification
• Essential documents is now referred to as essential records

Are there any changes to who can be an investigator in a clinical trial?

Yes, under the revised regulations, who can be an investigator has been significantly expanded and now a much broader pool of health care professionals can act as investigators. ​Those professionals must be registered with their relevant regulator, such as the nursing and midwifery council, general medical council and health and care professions council.​ The healthcare professional should be appropriately trained to undertake that role in a clinical trial and will need appropriate support for any medical decisions in regard to the trial. Always refer to your protocol and local policies and procedures.

What are the main changes we need to know about in the new clinical trial regulations?

A brief overview of the main changes summarised below:

• Approvals – The way research teams seek approval from a Research Ethics Committee and the MHRA for new Clinical Trials of Investigational Medicinal Products (CTIMPs) will be put into law for the first time, embedding a single application route and co-ordinated regulatory and ethics review. Timelines for approvals will also be changed and the process streamlined.
• Transparency - The new regulations require clinical trials to be registered on a WHO-recognised public register. The sponsor will be required to publish a summary of results on the same public registry within 12 months of the trial ending, and it will be a regulatory requirement to offer to share a summary of results with participants in a suitable format, in a way that is understandable to laypersons.
• Safety reporting and pharmacovigilance – The new regulations will simplify safety reporting requirements for study sponsors and remove duplicate safety reporting requirements that don’t add value to patient safety monitoring.
• Enhanced focus on risk and proportionality – A key objective for the revision to the regulations was to reinforce the use of risk proportionate approaches for the conduct of clinical trials. This is not a new concept and has been encouraged from the outset of the 2004 regulations. The revision makes it a requirement for organisations to adopt risk proportionality when thinking about their trials. Focus is on protection of the rights, safety and well-being of trial participants and the reliability of the trial results by paying attention to risk mitigation and processes relating to those factors that impact on this ‘Critical to Quality Factors’.