On 12 December 2024, the Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2024  were laid before Parliament. These were subsequently signed into law during April 2025 and will come into force on 28 April 2026 following a 12-month transition period. 

These amendments propose important changes to the processes involved in clinical trials in the UK. The focus of these amendments is to bring a greater level of harmonisation with EU regulation and international legislative standards, streamline the process for sponsors and increase flexibility while ensuring safety and transparency for patients. 

Background

The amendments to the Medicines for Human Use (Clinical Trials) Regulation 2004 are considered to be the most significant reform of UK clinical trials regulation in more than 20 years.

Despite the UK having attractive features for clinical trials such as academic and research excellence, national health coordination, and a diverse multi-ethnic population, according to the Association of the British Pharmaceutical Industry (ABPI) December 2024 report, the UK was, as of 2023, ranked 8th in the world when it comes to commercially-led phase III clinical trials. Additionally, ABPI data shows commercially-led clinical trial enrolment in the UK dropped by 44% between 2017/18 – 2021/22. In 2023, the UK Government commissioned a report from Lord O’Shaughnessy to find ways to resolve the challenges impacting commercial clinical trials.  Further information relating to the Lord O’Shaughnessy review may be found here. 

Implications of Amendments

Following O’Shaughnessy’s review and a public consultation, the UK Health Research Authority (HRA) and Medicines and Healthcare products Regulatory Agency (MHRA) proposed legislation to amend the current clinical trials legislation to address the needs of the sector while protecting the safety and interests of participants.

Bringing these regulations into law provides greater clarity to the UK regulatory process and allows for commercial sponsors to develop long-term internal policies. Additionally, these regulations demonstrate the UK’s position of remaining broadly aligned with the updated EU clinical trial regulation while still offering sponsors the flexibility necessary to grow the industry in the UK. 

Streamlined Application and Review Process 

The new UK legislation provides for a combined review system with the MHRA and Research Ethics Committee (REC). This reduces the need for sponsors to duplicate their work and ensures that they have long-term policies that comply with this system. 

The timelines for the process have also been consolidated. A combined review will occur within a maximum of 30 calendar days and a decision will be granted after responses have been received to any Request for Further Information (RFI) within a maximum of 10 calendar days (reduced from 16). The new legislation also provides greater flexibility for sponsors and increases the time sponsors have to respond to an RFI from 14 days to 60 days. 

This allows sponsors to develop robust responses to any questions and better align requests for changes from multiple regulators. For sponsors, this flexibility should be welcomed as it reduces the risk of rushing a response only for it to run into issues with another regulator, or of providing an insufficient response leading to an increase in the administrative burden on both ends. 

The new legislation also embeds a notification scheme for both initial applications and modifications into the process. This allows sponsors to receive automatic regulatory authorisation for trials considered low risk while still ensuring patient safety. It is important to note that under this scheme, the sponsor is responsible for determining if the clinical trial meets the eligibility criteria for notification. In this regard, there are two sets of criteria provided for in the new regulations: one for initiating clinical trials through the notification scheme, and the other one to make substantial modifications to the trial.   

Conduct and Transparency of Clinical Trials 

To improve transparency, public access and trust regarding clinical trials, the legislation sets out clear guidance on when to publicly register a trial. Additionally, trial sponsors must publish a summary of results within 12 months of the trial concluding and offer participants a summary written in a style understandable to a lay person. However, understanding the need to protect commercially confidential information, the legislation states that sponsors can request the publication of these results be deferred for up to 30 months. 

Failure to register or publish results will be considered offences under the new legislation and may result in an infringement notice by the MHRA.  Sponsors will need to keep on top of deadlines to reduce the risk of non-compliance and its repercussions. 

The 2004 regulation set out how clinical trials in the UK must be conducted in accordance with Good Clinical Practice (GCP). To ensure harmonisation and allow the UK to continue to meet international standards, the legislation updates the provisions to align both now and in the future with the principles of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) guidelines. This is important for commercial sponsors looking to conduct trials in the UK as it allows for the data generated in the UK to be globally recognised as having been generated in accordance with ICH standards. 

Safety reports are another important area of transparency. Currently these reports only need to include individual serious adverse events and reactions. However, with this legislation they will need to include a description of how these events and reactions have been evaluated and interpreted. Additionally, they will need to include mitigation actions that have been taken based on the signals and risks associated with the use of the medicinal product being investigated. 

Flexible and risk-proportionate regulatory environment

Alongside the guidance outlined above, the new legislation extends this approach to three further areas: ethics, labelling, and consent.

On ethics, the legislation provides for flexibility regarding how an ethics committee should be constituted, aligning with international GCP standards. 

On labelling, there is a focus on reducing duplication and allowing greater flexibility in the labelling and licensing of certain clinical trial medicines, particularly where existing authorisations and safety data are already in place. 

Regarding consent, sponsors and participants in lower-risk trials involving authorised medicines will be able to enter into simplified agreements. This is designed to make the process more accessible for participants while still ensuring they are adequately informed. An example given by the HRA is that GPs will be able to record a patient’s consent for a trial after seeking informed consent rather than the patient needing to sign a written consent form. Sponsors wishing to utilise these new arrangements must ensure that any healthcare professionals responsible for enrolling patients into trials are equipped with the necessary information to handle the informed consent process effectively.

Next Steps

The new legislation helps provide clearer guidance, streamlines processes, and improves the regulatory environment to improve patient access to commercially led clinical trials, encouraging sponsors to conduct UK-based trials. 

As mentioned, the new regulations come into force on 28 April 2026, which gives sponsors relatively limited time to ensure that they are compliant with the new requirements. It is expected that supplementary guidance will be provided by the MHRA and HRA before the regulations come into force. 

Should you require legal advice on this topic – or any other regulatory matter relating to the life sciences and health care sector in the UK or across the world – please do not hesitate to reach out to the authors of this article.

This article was authored by Pieter Erasmus (Senior associate, London) and Doyin Oyekan (Spring vacation scheme student, London).