Clinical trials in the UK: Forthcoming regulatory changes and priorities for implementation
Estimated reading time: 10 minutes
Dr Kingyin Lee, head of clinical trials at the MHRA, and Clive Collett, head of policy and engagement at the Health Research Authority (HRA), discuss upcoming regulatory clinical trial changes to help place the UK as a leader in this space and provide greater clarity for participants
At a recent Westminster Health Forum Policy Conference on next steps for clinical trials in the UK, the Medicines and Healthcare Products Regulatory Agency (MHRA), and the Health Research Authority (HRA), gave an overview of forthcoming changes to clinical trials regulations. These will come into force at the end of April 2026.
Dr Kingyin Lee, head of clinical trials at the MHRA, began by advising on the rationale behind the need for change.
“The current UK clinical trial regulations are based on the now repealed2001 EU Clinical Trials Directive,”Kingyin said. “We have left the European Union, and we have an opportunity to create a world-class regulatory environment for clinical trials, delivering a modernised framework that supports the safe development of innovative treatments.”
Several reviews, reports and research activities have fed into the forthcoming regulatory changes, Kingyin added. For example, the government’s10 Year Health Plan for England,itsLife Sciences Vision,theLord O’Shaughnessy reviewand MHRA’s 2022 consultation on proposals for the legislative changes.
“They have all culminated in the main point for the need to speed up the approval process and to provide a framework that is streamlined, agile and responsive to innovation, to help position the UK as a destination for international clinical trials,” Kingyin explained. “Increasing transparency for participants who are involved in clinical trials is another important component.”
Legislative updates and key changes
Providing an overview of the legislative updates, Kingyin began by explaining that the clinical trials approvals and application process will become more efficient and risk proportionate. “There will be a single route of application and approval, and the timelines will reflect that flexible and agile response to what our applicants in the clinical trials landscape need,” he told the conference. “Good Clinical Practice (GCP) will also be embedded into the legislation for the first time, and this means both the data and how the trial is run will align with international trials to create better compatibility.
“We’re trying to remove the duplications and the red tape that goes with running a clinical trial,” he continued. “In terms of pharmacovigilance, we will be removing requirements for duplicated reporting, for instance in annual reports. In the legislation, we will also have changes in terms of manufacturing, and we will be defining what a non-investigational medicinal product is. As part of this, radiopharmaceutical flexibilities and labelling flexibility will be put in.”
He added that the path to regulatory reform has been ongoing since 2022, and since April 2025, the MHRA has worked through consultation feedback to generate the new guidance for clinical trials in the UK. “We are now at a stage where we are ready to go live,” he said.
Route A modifications
As part of the new regulations, the MHRA will ensure that all clinical trial applications will undergo combined review. “This means that the MHRA and HRA ethics review will be performed on the same timeline,” Kingyin noted.
He also confirmed that the MHRA will introduce a notifiable period that will span across all phases for applications. “This is again a risk appropriate approach with a 14 day automatic approval built in, when eligibility criteria is met,” he said.
There will also be terminology changes in the new regulations, Kingyin confirmed. “We currently have substantial amendments, this will become known as Route A modifications. They are essentially the same assessment, but with a new timeline. A validation step has been introduced and this is a seven-day period whereby all applications have to be checked to ensure they are appropriately submitted.
“From our experience, this essentially will eliminate up to one in 20 trial applications that would otherwise have become invalidated at the end of the day,” Kingyin told the conference. “We want to make sure that we can help to approve trials, not reject them too early, so we will continue with what we did previously with the assessment. We have a 30-day assessment period followed by a request for information (RFI), and this will replace the terminology of grounds for non-acceptance (GNA).”
He said one of the current issues is when an RFI or a GNA needs to be issued, this would commonly lead to a rejection. This was the rationale for introducing a validation step to enable any issues to be ironed out to prevent applications from being rejected, he added.
The current 14 day timeline for sponsors to respond to MHRA’s requests for information will be increased to 60 days, he explained. “This is to allow for international trial harmonisation and to provide sponsors with more time, should they need it. This is a sponsor-driven change and whichever time that a sponsor applicant is required to respond to an RFI, we will promise and guarantee a 10 day review of that response and a final decision,” he said.
Potential for automatic approval
When a clinical trial has sufficient scientific evidence that already exists, there will be a potential for automatic approval, Kingyin advised. For example, where the methodology used is essentially the same, or when it has previously been reviewed and approved by the MHRA or by the European Union (EU), European Economic Area (EEA) or United States. “If these conditions were to apply, the trial would go under fast track approval of 14 days,” he confirmed.
“It would obviously have to conform with the criteria that we have in MHRA guidance, and have no significant safety concerns,” he continued. “Otherwise, it will need a full regulatory assessment.
“We are very keen to ensure that participants are kept safe, so trials involving participants from higher risk populations such as children and pregnant or breastfeeding women, will not be eligible for the fast track approval process. In addition, medicines that carry higher risk of uncertainties, for example, those tested for the first time in humans or advanced therapy medicinal products, will also not be eligible for this process,” Kingyin said.
Route B modification
Non-substantial amendments will be known as Route B modification in the new regulations, he told the conference. These are minor changes to a trial which do not require the need to notify MHRA.
“We are splitting this into two types of change,” Kingyin explained. “However, the changes will be administrative. For example, if you are changing the name of a sponsor, legal representative or updating contact details, this just needs to be notified to us so we know who to contact. But there isn’t any assessment that is needed. These will go ahead without approvals and the minor modification will become the rest of the non-substantial amendments in the MHRA’s sphere of handling these types of changes.”
Route B modification will also be applied to trials that are unsuitable for the fast track approval process. “We would need to know there are no significant safety concerns with the changes in your clinical trials, and there are no new safety concerns with regard to the medicines used within that trial,” he explained.
Any modification to a trial on the Route B process has to comply under three conditions to be potentially eligible, he advised.
“The trial must not involve a first in human investigational product, and the modification has to have been approved by a recognised authority,” he explained. “Secondly, the trial has to be limited to a specific set of changes in trial protocols, such as certain aspects of study design, objectives and measurements.”
For condition c, modifications must be limited to a specific set of changes in the investigator brochure or summary of product characteristics, he confirmed.
“If a trial modification does not indicate any significant safety concern changes, then there is the potential for it to fall under the risk proportionate approach of 14 day automatic approval,” he said.
In October 2025, the MHRA started a pilot of Route B modifications. This has been running successfully, and so far, 18 clinical trial applications have gone through this procedure, Kingyin advised.
Research transparency changes
Next, the conference heard from Clive Collett, head of policy and engagement at the Health Research Authority (HRA) on the forthcoming changes to research transparency requirements for clinical trials involving medicines.
“With the new amended clinical trial regulations coming into force on 28th April 2026, sponsors of clinical trials of investigational medicinal products (CTIMPs), must register their clinical trial in a public registry before the recruitment of the first participant, or within 90 days of the approval of the trial, whichever is the sooner,” he told the conference.
“Sponsors must also publish a summary of the results within 12 months of the end of the trial, and they must offer to share a summary of the results with participants, in a suitable format, and in a manner that is understandable to individuals who have taken part in the study,” he explained.
The HRA takes commercial confidentiality seriously so there will continue to be a system of deferrals from those requirements, where required, he added. “Deferrals from the research transparency requirements will be allowed, where they can be justified, particularly for commercial confidentiality, for 30 months following the global end of the clinical trial.”
Phase I trials with healthy volunteers will be granted an automatic deferral up until 30 months after the end of the trial for all of the transparency requirements, the HRA’s head of policy and engagement explained. “Sponsors will not have to ask for this, the deferral will be automatically granted and applicable for all Phase I trials with healthy volunteers. Although, it is up to the sponsor if they want to take advantage of this,” he added.
Extensions to deferrals may be agreed up to a maximum period of 10 years after the end of a clinical trial, where this can be justified. They would be most likely seen in “really extreme cases of commercial confidentiality, attributable to really early phase trials”, he added.
Research ethics committees (RECs) and their composition will also change in the legislation. The new regulations will align with international good clinical practice standards (ICH-GCP E6), he advised, and remove the “very granular and specific requirements” for REC committee composition. This will give ethics committees greater flexibility to meet demand and respond to situations, while still meeting international standard, he added.
Simplified arrangements
The new regulations will also offer sponsors of CTIMPs that meet particular conditions, the option to use simplified arrangements for seeking and evidencing informed consent. This is designed to reduce the burden and increase flexibility while still safeguarding participants, Clive told the conference.
“This is not about the erosion of the importance of informed consent, it is merely about the arrangements for seeking that informed consent,” he explained. “We would like to see greater adoption of this proportionate approach in low intervention, low risk trials, and this is supported by the new legislation.”
Simplified arrangements would only apply to trials using medicines that are already authorised and have no additional interventions or medicines. “We’re currently in the process of developing a series of overarching principles on the simplified arrangements for consent to support these trials in existing medicines, while maintaining public trust,” he added. “Those principles will help sponsors consider what simplified arrangements would be suitable under the new changes to the regulations.”
Both theMHRAand theHRAhas produced guidance to support the introduction of the new amended regulations for clinical trials in the UK.
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