Article
November 10, 2025
UK Clinical Trial Regulation 2025: Key Updates for Sponsors
The UK has officially signed into law a major overhaul of its clinical trial regulations, with full implementation set for 28 April 2026. This reform represents the most significant update in over 20 years and is designed to make the UK a more attractive and efficient location for clinical research. This document highlights the key points impacting clinical trial sponsors.
Key Points
- UK Clinical Trial Regulation signed into UK law under Statutory Instrument 2025/538.
- Requirements of the regulation come into force from 28 April 2026.
- Regulation provides legal framework around a number of updates that have been made to the UK clinical process, such as the combined review process.
- Introduces additional transparency and puts patients and safety at the forefront of clinical research.
- Many of the regulation requirements align the UK with EU Clinical Trial Regulation (No) 536/2014.
- In general, the GMP impact of the regulation is relatively minimal, but there is an introduction of some minor changes to label text requirements for UK trials under the regulation.
Expeditious approval of some Phase III and IV clinical trials
In October 2023 it was announced1 that certain low risk phase III and phase IV trials would be processed in 14 days instead of the statutory 30 days.
Criteria to qualify for phase IV trials include2
- Investigational Medicinal Products (IMPs) are licensed and used in accordance with the marketing authorization (MA (or equivalent) for UK, EU, or USA)
- No ongoing safety concerns
For phase III trials, they must meet one of the criteria:
- Trial is already USA or EU approved with same protocol, investigator brochure and IMPD version (applicable to EU approved trials)
- MHRA approved within the past two years a phase III trial of the IMP at the same or higher dose, or
- IMPs are licensed and used according to UK, USA, or EU MA
Exclusion criteria include:
- Complex trial design
- Paediatric patient population
- Pregnant or breast feeding patient population
- IMP is first in class
- IMP is an Advanced Therapy Medicinal Product
UK consultation on Clinical Trial Regulation
Alongside this, the UK government undertook a public consultation3 to review clinical trials regulation within the country. The outcome of the public consultation resulted in a revision to the clinical trial regulation within the UK, which was laid before parliament in December 2024.4, 5
In presenting the legislation to parliament, ministers commented that “The revised legislation aims to reduce unnecessary administrative burdens on trial sponsors while keeping participant safety at the forefront.” Four key benefits were highlighted that the new legislation would bring:
- Create a proportionate and flexible regulatory environment
- Cement the UK as a leading destination for international trials
- Moving away from a one-size-fits all approach, to be responsive to innovation
- Ensure patients and their safety are at the focus of all clinical trials and supported by greater transparency that bring the benefits of clinical trials to everyone
The Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025
On 11th April 2025 it was announced that the revised Clinical Trial Regulation had been signed into UK Law.6 A 12-month roll-out began on the day of the announcement with the new regulation taking full effect from 28 April 2026.
The Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025 have been published under Statutory Instrument 2025/538. Some of the key points within the amended regulation7 are reviewed below.
Throughout the regulation, the term “subjects” has been changed to “participants.”
The UK has retained the use of term Non Investigational Medicinal Product (NIMP), EU equivalent Auxiliary Medicinal Product (AxMP): “non-investigational medicinal product” means a medicinal product used or to be used in a clinical trial, as described in the protocol, but not as an investigational medicinal product.
The requirements set out for NIMPs in the regulation state that they must be manufactured or assembled in accordance with the principles and guidelines of good manufacturing practice, comply with safety standards applicable to that product; and be listed in the investigational medicinal product dossier with information about its properties, labeling, manufacture and safety controls, appropriate to the product.
A wholesale dealer’s licence (WDA(H)) should be used if you import authorized or unauthorized products from a listed country (all EU and EEA countries) for use in a UK clinical trial in Great Britain that are:
- non-investigational medicinal products
- unmodified comparators to be labeled in Great Britain before QP certification and release to the clinical trial
Importation from a country that is not a listed country will require a manufacturers import authorization (MIA-IMP) licence.8
Regulation 11 has been updated and gives clear requirements in regard to changes to trials, some of the key concepts are included below:
- “modification of an important detail” means a modification to a clinical trial approval which — the authorities should be aware of for administrative or oversight purposes, but does not significantly impact the safety or rights of the participants
- “modification to a clinical trial approval” means a modification to—
- the terms of the request for approval of the clinical trial,
- the particulars or documents accompanying that request for approval, or
- where the request for approval of the clinical trial was made under regulation 16(5)—
- the terms of the request for authorization to conduct that trial,
- the application for an ethics committee opinion in relation to that trial, or
- the particulars or documents accompanying that request for authorization or application for ethics committee opinion
“Route A substantial modification” means a modification to a clinical trial approval which is 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.
“Route B substantial modification” has the meaning given in regulation 11B.
New regulations 11A and 11B formalize the requirements of notifiable trials (those subject to expeditious processing) and Route B substantial amendments (essentially similar to the requirement for expeditious processing).
Regulation 16-24 lays the framework for the combined approval process and modifications to approved trials. Of note it states that applications and modifications must be made via an online portal. Confirmation that an approval is valid must be given within 7 days of submission.
The content of the submission is given:
- A completed application.
- A statement or cover letter drawing attention to any features which are particular to the clinical trial, if required.
- The protocol for the proposed trial describing the objective, design, methodology, statistical considerations, purpose and organisation of the clinical trial.
- The investigator’s brochure or equivalent document.
- The following documents or, in each case, an explanation of why that document is not being provided:
- documentation relating to compliance with the principles and guidelines of good manufacturing practice, where applicable.
- a dossier providing the following information or cross-referring to the investigator brochure if it contains such information
- details of the quality of any investigational medicinal product or non-investigational medicinal product,
- details of the manufacture and control of the investigational medicinal product, and
- data from non-clinical studies and from clinical use of the product.
- a copy of the scientific advice of the licensing authority, or of any third country, with regard to the clinical trial.
- a description of the content of the labeling.
- all information given to the participants, or their legal representatives, before their decision to participate or abstain from participation in the clinical trial.
- proof of insurance, a guarantee, or any other similar arrangement, where applicable.
- responses to areas for discussion raised by the Commission on Human Medicines, where applicable.
The outcome of the review can be one of the following:
- approve the request for approval,
- approve the request for approval, subject to conditions specified in the notice, or
- do not approve the request for approval, setting out the grounds for this decision.
In general, the review process should be completed 30 days after the sponsor was notified that their application was valid. This time period may be extended by 90 days if there is a requirement to consult a relevant committee or a specialist group. Furthermore, if the clinical trial involves a medicinal product for xenogeneic cell therapy, the time periods mentioned above are not applicable and the authority may give their decision at any time after the date on which the sponsor was notified that the request for approval was valid.
If the sponsor is given a notice which contains a request for further information the sponsor may send an amended request for approval within 60 days or an extended period if the authority allows it.
This section also defines that if the combined application route is not followed, then the timing of review and decision apply separately to the individual applications. Furthermore, sponsors are reminded that under the separate application route the trial is not approved until a favourable opinion has been given by both licensing authority and the ethics committee.
A sponsor may make a modification to a clinical trial approval, other than a substantial modification, at any time and without the need for submitting a request under this regulation, in such cases the sponsor must keep records of the modifications and make those available upon request. If a sponsor makes a modification of an important detail, the sponsor must notify the authorities of the modification through an online portal made available for this purpose.
Substantial modification to a clinical trial approval are handled via the online portal. The regulation sets forth the requirement for the authority to review and provide a decision on substantial modifications Regulation 25 defines the requirements for transparency and states within the period of 12 months beginning with the day after the conclusion of the clinical trial, the sponsor must publish a summary of the results of the clinical trial and make a layperson summary available.
Regulation 26 states that the clinical trial approval lapses at the end of the period of 24 months beginning with the date of approval of the trial if there are no participants recruited to take part in the trial.
The requirements for recording and reporting adverse events have been amended.
Labeling requirements are set forth in Regulation 46.
For unauthorised IMPs the following label text particulars are required:
- the words “for clinical trial use only”;
- a warning that the product must be stored out of the reach and sight of children (unless the product is to be exclusively administered in a hospital or health centre taking part in the clinical trial);
- information to identify the sponsor and contact persons involved in the clinical trial;
- information to allow identification of the clinical trial, for example the clinical trial reference code;
- information linking the product to the participant, for example, the participant identification number;
- information to allow identification of the medicinal product, including—
- the common name of the active substance,
- the strength and pharmaceutical form,
- the contents by weight, volume or number of doses, and
- the batch or code number;
- information related to the use of the medicinal product, including—
- instructions for use (which may be by reference to a patient information leaflet),
- method or route of administration,
- expiry date, and
- any special storage precautions; and
- in the case of trials in which blinding occurs, the name of any comparator or placebo product used alongside the investigational medicinal product.
Transitional arrangements for label text decree that anything manufactured (which include QP certification) prior to 28 April 2026 can be utilized using existing label text. Thereafter it is expected that all new material subject to release would be in compliance with the label requirements determined above.
Authorized products used as IMPs should be labeled as described above or if their labeling is in compliance with Part 13 of the Human Medicines 2012 Regulations, no further labeling is required. NIMPs are required to be labeled as above unless they are exclusively administered in a hospital or health centre.
Conditions applicable to all clinical trials are described; they must be conducted in accordance with principles of Good Clinical Practice, in accordance with the Declaration of Helsinki, investigator and sponsor must follow all guidance in relation to commencing and conducting a trial, provision must be made for insurance and indemnity to cover all liabilities of the sponsor and investigator which may arise.
The regulation concludes with provisions for transitions and applicability of old rules vs the new requirements of the regulation.
Conclusion
The updates to the UK clinical trial framework are welcomed and aligns with many of the features that were introduced as part of the EU Clinical Trial Regulation. The UK is clearly seeking to position itself as a country at the forefront of clinical research, offering sponsors a quick approval route to getting trials initiated.
Links
4. Written statements – Written questions, answers and statements – UK Parliament
6. https://www.gov.uk/government/news/clinical-trials-regulations-signed-into-law
7. The Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025
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