Last updated: 28 April 2025
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How were these reforms developed?
The reforms were developed through a series of stakeholder workshops, seeking the views of a wide range of organisations and individuals from across the clinical research sector, including patient representatives.
A public consultation took place in January to March 2022, to which over 2,000 responses were received, and the Government response was published in March 2023.
When was the new clinical trials draft legislation laid in parliament?
New clinical trials draft legislation (Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2024) was laid in Parliament on 12 December 2024 to:
- address the research sector’s need for a more efficient, streamlined and adaptable regulatory framework for clinical trials.
- make the UK a more attractive place for innovators to conduct important research and to help to get potentially life-changing new treatments to patients and the NHS as quickly as possible.
Here is a link to the statement made in parliament by Baroness Merron on 12 Dec 2024 concerning laying of the Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2024 before Parliament.
When did the new clinical trials regulations become law?
The New UK clinical trials regulations (link awaiting update to approved status) were signed into law on 11 April 2025.
When will the new legislation come into force?
A 12-month roll-out began on 11 April 2025 to deliver the most significant update to UK clinical trials regulation in two decades – with the aim of:1
- strengthening patient safety,
- accelerating approvals,
- enabling innovation and
- helping more people benefit from taking part in vital research.1
The new legislation will take full effect from 10 April 2026 following a 12-month implementation period to ensure readiness, aims to reduce unnecessary administrative burdens on trial sponsors without compromising patient safety.
What are the expected benefits of the new legislation and regulatory framework for clinical trials?
The reforms will1:
- Put patients and their safety are at the focus of all clinical trials and bring the benefits of clinical trials to everyone.
- Cut duplication and unnecessary delays, while maintaining robust oversight of the safety of trials.
- Create a proportionate and flexible regulatory environment, reducing bureaucracy for lower-risk trials.
- Cement the UK as a destination for international trials.
- Provide a framework that is streamlined, agile and responsive to innovation.
By reducing red tape and simplifying approvals, the new framework supports the Prime Minister’s target to reduce the time from application to first participant from 250 to 150 days. It will speed up research and reduce the time it takes for promising treatments to reach patients, without compromising on safety.1
The Combined Review – a system that lets researchers apply for ethics and regulatory approval in one go – and notification scheme for some clinical trial initial applications and amendments will now be written into law as part of the changes.1
What reforms proposed in the draft legislation have full implemented been implemented in the final approved regulations?
The key reforms to UK CTR proposed in the December 2024 draft legislation have been fully implemented in the final version of the amendment regulations and include:7
- Risk-proportionate Regulation:
- Regulatory requirements now align with the risk level of clinical trials.
- Low-risk trials can receive faster approval through automatic authorisation without comprising patient safety.7
- Streamlined Approval Process:
- A combined review process integrates regulatory and ethics committee approvals, leading to a single UK decision for decision for clinical trials.
- This aims to reduce duplication and unnecessary delays while maintaining robust oversight of trial safety.7
- Enhanced Transparency Requirements:
- New legal obligations mandate the registration of clinical trials in public registry and the publication of trial results within 12 months of the trail’s conclusion.
- This initiative aims to build public trust in research by improving access to information about ongoing studies.7
What key elements have also been confirmed in the final approved regulations?
The following key elements have also been confirmed in the final amendment regulations:7
- Notification Scheme for Low-Risk Trials:
- A notification scheme has been introduced for lower-risk clinical trials, enabling sponsors to notify the MHRA about eligible trials where the risk to participant is similar to standard medical care.
- This streamlined process facilitates faster initiation of these trials without compromising safety.7
- Extended Archiving Period:
- The regulations now require the archiving of trial master files for 25 years, an extension from the previous 5-year requirement.
- This change ensures long-term accessibility to trial data for future reference and analysis.7
- Sunset Period for Trials Approvals:
- Clinical trial approvals will now lapse after a proposed sunset period of two years if no participants have been enrolled.
- This measure encourages timely initiation of trials and optimises resources allocation.7
Will there also be new guidance published in addition to the new clinical trials regulations?
Yes, alongside the regulations, the MHRA and HRA are producing guidance to embed meaningful public involvement in clinical trials and increase the diversity of people taking part in research trials. This will ensure that research findings can improve everyone’s care, helping address health inequalities.
The proposed times of the guidance is as follows:6
| Date | Guidance |
|---|---|
| Nov 2024- Mar 2025 | Engagement activities with stakeholders |
| Mar – Apr 2025 | Final draft guidance to be published |
| Apr – June 2025 | Further comments on the final draft guidance |
| Aug 2025 | Final version of the adopted guidance to be published. |
| Jan 2026 | Guidance becomes ‘live’ subject to parliamentary processes |
What are the topics on which guidance will be published?
The guidance topics are roughly the following2:
- Requesting approval of a clinical trial
- Modification to a clinical trial approval
- Notifiable trials and the notification scheme
- Reporting safety issues
- Research transparency
- Simplified means of seeking and recording consent
- End of a clinical trial and transitional arrangements
Webinars
- Here is a link to the MHRA webinar of 15 October 2024 entitled Implementing the new UK Clinical Trials Regulations and a link to a blog post on the webinar.
- Here is a link to the MHRA webinar of 25 February 2025 entitled Guidance accompanying the new clinical trials regulations.
A summary of the webinar of 25 February 2025 has been provided below with the help of the chatbot Google Gemini.
This webinar, presented jointly by the MHRA and the HRA, focuses on the guidance supporting the new clinical trial regulations [00:08].
Here’s a summary of the key topics discussed:
- Application for Clinical Trial Approval: This includes a new notification approach [04:42]. The MHRA will provide more clarity on timelines, trials not submitted through combined review, and documentation requirements [06:23]. For notifiable trials, the inclusion/exclusion criteria will be clarified, and more information will be provided on the process if a trial is objected to [11:03].
- Applying for Approval to Modify Clinical Trials: The term “modification” replaces “amendment” in the new regulations [04:56]. The criteria table for Route B modifications will be separated, and a decision tree/flowchart will be included to help identify the most appropriate submission route [13:29].
- Safety Reporting: The final guidance will include specific guidance on reporting placebo-related events, align with ICH E2F guidelines, provide more DSUR example scenarios, clarify the DSUR submission process, detail how to notify urgent safety measures, and include a section on reporting serious breaches [16:26].
- End of a Clinical Trial and Transitional Arrangements: The updated guidance will include a section on temporary halts, clarify the definition of a temporary halt, include reasons for temporary halts, clarify that a trial cannot restart until a substantial modification is approved, and include a diagram to explain the process [18:10]. For transitional arrangements, the guidance will reword references to trials submitted under old vs. new rules, clarify processes for trials assessed or migrated into combined review vs. those still ongoing under non-combined review, and clarify labeling aspects [20:21].
- Transparency Requirements and HRA Guidance: The HRA guidance will cover aspects such as research ethics committee constitution and membership, transparency requirements (registration of trials, publishing summary results, sharing results with participants), and the deferrals process [22:02].
The MHRA and HRA are working together to ensure consistent guidance, with the HRA planning to publish its guidance in sync with the MHRA [22:21]. Stakeholder feedback is being incorporated into the guidance, with opportunities for further input [24:50]. The next steps involve waiting for approval, updating the guidance based on feedback, and publishing it [28:10].
Further reading
New Clinical Trials Regulations will bring UK closer to EU regime, Rory Trust, Burges Salmon, 22 April 2025
References
1. Clinical Trials regulations signed into law, 11 April 2025, MHRA
2. New Year Update: incoming changes to UK regulation of clinical trials, Jackie Mulryne et al, 13 January 2025, Arnold & Porter.
3. Framework amending the UK clinical trial regulations laid before Parliament, Jane Summerfield et al, 17 December 2024, Hogan Lovells
4. Patients, the NHS and the Life Sciences sector set to benefit from new clinical trials framework being laid in parliament today, Press release, 12 December 2024, MHRA
5. New clinical trials regulations laid in parliament today, Health Research Authority, 12 December 2024
6. MHRA webinar of 15 October 2024 entitled Implementing the new UK Clinical Trials Regulations (see link above in section Webinar.)
7. Reforms to UK clinical trials framework passed into law, Jane Summerfield et al, 24 April 2025, Hogan Lovells