Articolo

The drivers and benefits of the UK’s clinical trials regulation amendment

  • Xandra Neuberger

  • Lucy Gluyas

UK proposes new clinical trials regulation that minimizes administrative burden in push to attract more clinical studies
Since leaving the European Union, the United Kingdom has sought to find ways to strengthen its clinical trials regulations to maintain the highest standards and remain competitive. The UK currently operates under the Medicines for Human Use (Clinical Trials) Regulations 20041 which is based on the EU Clinical Trials Directive.2

In response, the Medicines and Healthcare products Regulatory Agency (MHRA) and the Health Research Authority (HRA) collaborated on updates to the UK’s clinical trials regulation which were signed into UK law on 28 April 2025. 

The amended legislation is the Medicines for Human Use (Clinical Trials) (Amendment) Regulations 20253  and a 12-month implementation period is in place. As such, the amended legislation will be fully in force on 28 April 2026. The changes aim to provide a more flexible regulation, while minimizing the administrative burden on trial sponsors and maintaining patient safety.4

Attracting clinical trials

There has been a push to attract more clinical trials to the UK, which had seen a decline in the number of clinical trials initiated when compared with other countries.5 Reversing this trend is important both from an economic perspective as well as to improve early access to innovative medicines for UK patients.
 
The amended legislation includes the combined review where the MHRA and Research Ethics Committee assess clinical trial applications in parallel. While the combined review service is already in place, this will be the first time it has been written into law.6 The amended legislation also requires that the MHRA and REC review applications within a maximum of 30 calendar days from validation, and 10 calendar days for a decision after an amended request for approval has been received.7 However, there are certain circumstances where these timelines are extended. 

In addition, notifiable trials are now written into legislation for certain CTA applications that meet specific criteria, which would negate the requirement for a full review period and the associated delay in starting the trial. 

Comparison to the EU approach

Many of the proposed UK clinical trial regulation updates are comparable to the EU’s Clinical Trials Regulation (CTR).8

This is not surprising given that the MHRA was one of the leading agencies in the EMA before Brexit and would have played a key role in the development of the Clinical Trial Information System (CTIS). The functional specifications for the EU portal and database were laid out in a 2015 EMA document, including the technical features needed to support the publication of clinical trial information.9

One notable similarity is the transparency requirement. In the EU, revised CTIS transparency rules state that information in the EU database should be public with certain exemptions, including protecting personal data and protecting commercially confidential information.10
research
Similarly, the UK amendments place an emphasis on transparency. In an update shared by the NHS, the Director of Research Policy at the Association of Medical Research Charities, Dr. Catriona Manville, stated: “The new clinical trial regulations will help to embed transparency at all stages of the research process – from trial registrations right through to reporting to participants. Making research and its results publicly available is fundamental to building trust and encouraging participation.”11

This inclusion brings the UK into closer alignment with the EU, and also with the United States, where extensive information about clinical trials is published.12 Having this consistency across different markets enables sponsors to follow a streamlined publication strategy, where what is classified as confidential information is decided at the outset. In so doing, sponsors can have a clear and consistent approach to how they write their clinical trial documentation. While the transparency rules have been drawn up with the patient in mind, there is an opportunity for sponsors to take advantage of what ultimately is greater harmonization of requirements. 

The future for trials in the UK

The new legislation is an important step to achieving the objective of bringing more clinical trials to the UK and strengthening its position as a place of international clinical trials. Moreover, the UK remains an attractive market for many reasons – its hospital infrastructure, respected research and laboratory facilities, and specialty doctors, particularly in rare diseases.
*Sources continued below

About the authors:

Xandra Neuberger is Associate Director Regulatory Affairs and international service lead for clinical trial applications, leveraging her extensive experience with clinical trial applications and life cycle management to support the industry.  She also handles project and team coordination in her role. Xandra is a registered pharmacist in Germany and has also practiced pharmacy in the UK.

Lucy Gluyas is Senior Manager, Regulatory Affairs, and has been with the company since 2016. She project-managed numerous multi-national EU Clinical Trial Authorisation submissions from a Regulatory perspective under the Clinical Trials Directive and has since focused on UK Clinical Trial Authorisation Applications and Lifecycle management. 


Disclaimer:
The information provided in this article does not constitute legal advice. Cencora, Inc., strongly encourages readers to review available information related to the topics discussed and to rely on their own experience and expertise in making decisions related thereto.
 


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Sources:


1. The Medicines for Human Use (Clinical Trials) Regulations 2004, https://www.legislation.gov.uk/uksi/2004/1031/contents/made
2. Clinical trials - Directive 2001/20/EC, European Commission. https://health.ec.europa.eu/medicinal-products/clinical-trials/clinical-trials-directive-200120ec_en
3. The Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025, https://www.legislation.gov.uk/uksi/2025/538/contents
4. Patients, the NHS and the Life Sciences sector set to benefit from new clinical trials framework being laid in parliament today. Gov.UK, Dec 2024. https://www.gov.uk/government/news/patients-the-nhs-and-the-life-sciences-sector-set-to-benefit-from-new-clinical-trials-framework-being-laid-in-parliament-today
5. Rescuing patient access to industry clinical trials in the UK, abpi. https://www.abpi.org.uk/media/fjhnjz34/rescuing-patient-access-to-industry-clinical-trials-in-the-uk.pdf
6. New clinical trials regulations laid in parliament today, NHS, Dec 2024. https://www.hra.nhs.uk/about-us/news-updates/new-clinical-trials-regulations-laid-parliament-today/
7. MHRA to streamline clinical trial approvals in biggest overhaul of trial regulation in 20 years, MHRA, March 2023. https://www.gov.uk/government/news/mhra-to-streamline-clinical-trial-approvals-in-biggest-overhaul-of-trial-regulation-in-20-years
8. Revision of section 6 of the “Functional specifications for the EU portal and EU database to be audited -
EMA/42176/2014” setting out features to support making information public, EMA, March 2015.
9. Revision of section 6 of the “Functional specifications for the EU portal and EU database to be audited -
EMA/42176/2014” setting out features to support making information public, EMA, March 2015. https://www.ema.europa.eu/en/documents/other/revision-section-6-functional-specifications-european-union-eu-portal-and-eu-database-be-audited-ema421762014-setting-out-features-support-making-information-public_en.pdf
10. Revised CTIS Transparency Rules, EMA. https://www.ema.europa.eu/en/documents/other/revised-ctis-transparency-rules_en.pdf
11. New clinical trials regulations laid in parliament today, NHS, Dec 2024. https://www.hra.nhs.uk/about-us/news-updates/new-clinical-trials-regulations-laid-parliament-today/
12. The Importance of Clinical Trial Transparency and FDA Oversight, FDA, 2023. https://www.fda.gov/news-events/fda-voices/importance-clinical-trial-transparency-and-fda-oversight

 

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