In a tight funding market, the ability to generate early clinical data at speed can be an important driver of value. First-in-human data is increasingly seen as a key step to validate a drug candidate and attract investors and partners. Pace and efficiency are key, with fit-for-purpose regulatory processes increasingly important. The UK’s health data environment is often seen as a strategic advantage for clinical research, combining a large publicly funded healthcare system, longitudinal patient records, a diverse population and established research infrastructure.
With the overhaul of the UK’s clinical trials system now in place (discussed here) a new system offers an agile, proportionate and innovation-friendly regulatory environment. Changes are intended to support more efficient assessment of first-in-human trials and a simpler start for lower-risk studies. The reforms also support greater use of approaches such as relevant overseas safety data and in silico modelling, where these meet UK requirements.
Extensive consultation and stakeholder engagement, together with pilot schemes for aspects of the new framework such as the Route B substantial modification pathway, have provided an opportunity to test elements of the system before full rollout.
The new system offers a streamlined process and faster timeframes for approval. A single application is submitted for combined review, which goes to both the Medicines and Healthcare products Regulatory Agency (MHRA) and a Research Ethics Committee (REC) at the same time.
The framework introduces time limits at each stage of the regulatory process, against the wider policy objective of reducing overall clinical trial set-up times to 150 days.
Detailed guidance has been published by both the MHRA and the Health Research Authority (HRA).
The MHRA guidance sets out full details of the new system to be followed for all new clinical trials. For trials already underway by 28 April 2026, transitional guidance is provided to explain where the old rules can still be applied and where an update to the new system is necessary.
The aim is to align with recognised international frameworks, enabling sponsors to work effectively across multiple jurisdictions. The guidance includes information on the implementation in the UK of the International Council for Harmonisation (ICH) guidelines ICH E6 Good Clinical Practice and ICH E8 (General Considerations for Clinical Studies), and country-specific annotations to these guidelines. It identifies areas of potential conflict with the Declaration of Helsinki, and how sponsors should address these if they arise.
The HRA guidance explains the main changes for investigators and RECs, providing practical advice on how to navigate the new system.
The reforms have generally been welcomed by industry stakeholders, but their success will depend on effective implementation, alongside related initiatives, to deliver the expected benefits in practice.
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