UK looks to overhaul clinical trial regulations

After a multi-year process, the UK government introduced draft legislation to amend its clinical trial regulations in December 2024. The proposed Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2024 marks the Medicines and Healthcare products Regulatory Agency’s (MHRA’s) largest overhaul of clinical trial regulations in two decades, aiming to create a more streamlined and efficient framework. 

The UK’s proposed framework follows efforts by other jurisdictions to update their own clinical trial regulations in recent years. The EU overhauled its framework in 2022 with the updated Clinical Trials Regulation (CTR), which aimed to standardise the procedures for obtaining approval for and conducting clinical trials. The provisions of the EU CTR are applicable from 31 January 2025. 

In the U.S., the Food and Drug Administration (FDA) recently issued final guidance on Decentralized Clinical Trials (DCTs) to allow the use of telehealth and other technology to move trials away from one central location. This flexibility supports a more representative trial participant population, which strengthens the evidence produced by the trial. The change would also help sponsors meet new requirements for increasing enrolment of underrepresented populations in clinical trials.

Key points from the UK legislation

The MHRA has developed an approach that seeks to leave room for innovation while still protecting patient safety. The new streamlined regulations are designed to make the UK a top choice for conducting clinical research. To support this aim, the MHRA has identified several goals for the new clinical trials framework:

• Ensuring that patients and their safety are the focus of all clinical trials
• Facilitating the evaluation and development of new or better medicines to benefit patients and society and improve public health
• Removing obstacles to innovation, whilst maintaining robust oversight of the safety of trials
• Creating a proportionate, risk-based, and flexible regulatory environment
• Cementing the UK as a destination for international trials by enabling trial sponsors to work across countries

For the first time, the regulation would also require that clinical trials be registered in a public register recognised by the World Health Organization (WHO) and that a summary of results be published within 12 months of the end of the trial. The goal is to enhance transparency throughout the research process.

The UK is also prioritising flexibility with this new proposal by supplementing the legislative framework with accompanying guidance that is more easily changed. In an industry that continues to advance and evolve, this adaptability may give the UK a competitive edge over the EU. Through the guidance, the MHRA and Health Research Authority (HRA) will seek to embed meaningful public involvement in clinical trials and increase the diversity of participants in research trials. This intention aligns with the FDA’s DCT guidance.

Looking ahead

There are many similarities between the EU CTR and the UK’s proposed legislation, but there are also some key differences that may complicate cross-border trials for sponsors. Under the CTR, legal representatives and clinical trial sponsors must be established in the EU. This means that contract research organisations (CROs) based in the UK will not be able to sponsor clinical trials in the EU unless they have established a presence in the EU. These CROs have been essential partners for U.S. and other non-EU companies trying to get products into the EU market.  

Companies that decide to conduct clinical trials in both the EU and the UK will face regulatory differences that increase compliance burdens. The UK clinical trials regulatory framework faces a 12-month implementation period after it is made into law and likely won’t come into force until early 2026. However, there will be a learning curve for companies implementing these new regulations and determining how they overlap with and diverge from rules in the EU and U.S. 

It will be interesting to see how many companies choose to conduct clinical trials in the UK versus those that opt to take advantage of the MHRA’s International Recognition Procedure (IRP), which leverages the expertise and decision-making of trusted regulatory partners in other jurisdictions to gain UK approval more quickly.

As a start, companies conducting clinical trials in the UK should review the proposed legislation and follow its progress through Parliament closely. There will be opportunities to consult on supplemental guidance and raise questions or concerns.

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