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Mathilda Davidson, partner at Osborne Clarke, writes that the UK’s clinical trials overhaul is about more than speed.
The UK’s most significant overhaul of clinical trials regulation in two decades came into force on 28 April. The reforms are intended to modernise the UK’s clinical research environment at a time when governments are competing aggressively for life sciences investment. They aim to make the UK a more attractive market for clinical research while maintaining confidence in patient safety and trial integrity.
For pharmaceutical companies, biotech businesses, contract research organisations and NHS partners, the changes are significant because they address longstanding frustrations around duplication, slow approvals and fragmented regulatory oversight.
While it is too early to assess whether the reforms will fulfil the government’s aims and ambitions, sponsors will ultimately assess the framework on practical experience rather than policy intent and, in particular, whether the new framework proves predictable and does in fact reduce delay in trial timelines.
Combined Review pathway
The most commercially significant change is likely to be the introduction of the Combined Review pathway. Sponsors previously had to navigate separate systems for ethics and regulatory approval, often facing overlapping submissions and inconsistent feedback. Delays in approvals add cost and often affect trial recruitment, manufacturing schedules and development timelines. Under the new framework, the MHRA and Health Research Authority now offer a single application route through the Integrated Research Approvals System for Clinical Trials of Investigational Medicinal Products and combined medicine and device trials. A more streamlined process should reduce administrative burden and operational frictions as well as create greater certainty for sponsors around planning.
The reforms also introduce a formal notification scheme for certain lower-risk trials. Trials of this nature are exempt from MHRA assessment, thereby streamlining the regulatory process, although approval by the Regulatory Ethics Committee remains a necessary prerequisite. As the relevant safety features have already been evaluated, only notification is required. Initial applications for the lowest-risk Phase 3 and 4 trials will be processed by the MHRA in 14 days rather than the usual 30, as long as sponsors can show that the trial meets the applicable criteria, including confirmation that the medicine under investigation does not give rise to any known safety concerns.
These changes reflect a broader risk-proportionate approach running throughout the new rules, with regulators signalling a greater willingness to tailor oversight according to the level of risk associated with a trial. Higher-risk studies will continue to receive detailed scrutiny, while lower-risk trials should encounter fewer procedural barriers.
There are also signs that the regulations have been drafted with modern trial delivery in mind. Replacing the term “trial site” with “trial location” recognises the increasing use of decentralised research models, including remote participation and community-based care. Expanding the range of healthcare professionals who can act as investigators may also support broader delivery of trials outside traditional hospital settings. Collectively, these changes reflect a wider recognition that clinical research is becoming more flexible, technology-enabled and embedded within routine care pathways.
Alongside these measures, the reforms reshape the UK’s approach to safety reporting and pharmacovigilance in clinical trials.
Under the previous framework, sponsors often had to duplicate reporting obligations by submitting safety information separately to the MHRA and the REC. From 28 April, Suspected Unexpected Serious Adverse Reactions and annual safety reports need only be submitted to the MHRA, regardless of whether the study went through the Combined Review pathway. For sponsors managing large multi-site or international studies, this should reduce operational complexity. The extension of the urgent safety measure notification window from three days to seven days is also likely to make a practical difference in complex studies where rapid coordination across multiple sites can be challenging.
At the same time, the reforms place greater responsibility on sponsors to monitor emerging safety signals and explain how those risks are being managed throughout the lifecycle of a trial. The new framework, therefore, shifts some emphasis away from duplicated reporting and towards ongoing oversight and accountability. In effect, the regime is placing greater trust in sponsors’ systems, judgment, and pharmacovigilance controls.
Transparency is another area where obligations have become more demanding.
Public registry
For the first time in the UK, there is now a legal requirement to register clinical trials involving medicines on a public registry before recruitment begins, or within 90 days of approval. Sponsors must also publish a summary of results within 12 months of trial completion and offer participants access to findings in a format they can reasonably understand.
Those requirements reflect growing expectations from patients, regulators and the wider public around access to clinical trial information. Transparency is being treated as part of responsible trial management that should be incorporated into trial planning from the outset. For sponsors, transparency will promote credibility and increase public trust around clinical research programmes.
More broadly, the reforms also align closely with the updated International Council for Harmonisation Good Clinical Practice guidelines, ICH GCP E6(R3), which came into force at the same time and similarly emphasise proportionate, risk-based oversight. This alignment reduces the risk of jurisdiction-specific compliance friction across international development programmes. For multinational sponsors, greater alignment with international standards should make the UK a more operationally attractive component of global trial strategies.
The UK’s ambition is to reposition itself as a more commercially attractive market for clinical research without weakening expectations around patient safety, transparency or data integrity. Striking that balance will determine whether these reforms meaningfully strengthen the UK’s competitiveness in a market where clinical trials are increasingly global, mobile and complex. Looking ahead, the success of the new regime will ultimately depend on implementation over the coming months and years. Sponsors are likely to pay close attention to how consistently the new rules operate in practice and how responsive regulators remain once applications begin moving through the revised framework at scale.
