The UK has initiated its most significant update to clinical trials regulation in over two decades. These reforms aim to streamline approvals, reduce administrative burdens, and foster innovation, positioning the UK as a leading destination for clinical research. At Florence, we’re proactively reviewing these changes to ensure our customers remain compliant and agile in this evolving regulatory landscape.​

The updated framework addresses several core priorities: safeguarding participant safety and rights, simplifying regulatory procedures, improving transparency, and aligning with evolving international standards and practices. Below, we delve into the main aspects of the legislation and what they mean for stakeholders across the clinical research ecosystem.

Updated Terminology

• “Subject” becomes “Participant”: Emphasises the active role and partnership of individuals in clinical trials.​
• “Trial Site” becomes “Trial Location”: Acknowledges that trials are conducted in diverse settings beyond traditional hospitals, including decentralised and remote environments.​

Faster Approvals for Low-Risk Trials

To accelerate research timelines, a new notification scheme enables expedited approvals for eligible notifiable trials. These typically include studies that:

• Pose no significant safety risks,
• Exclude vulnerable populations (e.g., minors, pregnant or breastfeeding individuals),
• Involve already authorised or comparable treatments.

This fast-track path aims to support innovation without compromising safety.

A New Approach to Trial Amendments

The revised regulations introduce a structured approach to handling modifications. 

• Modification of Important Detail: These are administrative updates that do not impact participant safety. Sponsors are required to notify the authorities through the designated portal, but no formal approval is needed.
• Substantial Amendments: These may proceed via Route A or Route B, with the appropriate route determined by the sponsor in accordance with the criteria set out in the amendment.
  • Route A: For changes likely to impact safety or data integrity. Requires review by both the MHRA and an ethics committee.

Route B: For substantial amendments unlikely to introduce new safety concerns. These also require dual approval, but may receive automatic MHRA decisions.

Combined Regulatory and Ethics Review

The reform introduces a single application process, known as a “request for approval,” combining both regulatory and ethics evaluations. The target response time is 30 days post a 7-day validation period, simplifying trial setup and ensuring consistency in decision-making.

Commitment to Transparency

• Mandatory Trial Registration: All trials must be registered in a public database before recruitment or within 90 days of starting, whichever comes first.
• Results Reporting: A summary of trial results must be made publicly available in the same registry within 12 months following the trial’s completion.

Participant Communication: Trial results must be offered to participants in a layperson-friendly format.

Good Clinical Practice (GCP) Alignment

Regulatory references to GCP are now explicitly aligned with the current version of the International Council for Harmonisation (ICH) GCP guidelines. This ensures that as the guidelines evolve—such as with the recent implementation of ICH E6 (R3)—sponsors and sites remain obligated to maintain compliance with the most up-to-date international standards.

Explore more: How Sites Can ensure they are aligned with ICH E6 R3 and How Sponsors Can Ensure Site Alignment.

Provisions for Simplified Consent

New provisions allow for simplified consent procedures under specific conditions, provided they are well-justified and pose no increased risk. This flexibility supports recruitment in challenging environments while preserving ethical standards.

Smarter Safety Reporting

• SUSARs (Suspected Unexpected Serious Adverse Reactions) continue to require expedited MHRA reporting, but the obligation to report these directly to investigators and ethics committees has been removed.
• Annual Reporting: Transitions from basic listings to comprehensive safety evaluations, including identified risks and mitigation steps.
• Urgent Safety Measures (USMs): Written reports now have a 7-day window, up from 3, allowing for more informed regulatory assessments and international harmonisation.

Risk-Based Reporting: Allows certain expected SUSARs specified in the protocol to be exempt from immediate reporting.

Recordkeeping and Archiving

The minimum record retention period has increased from 5 to 25 years. This change underscores the long-term value of trial data and the necessity of robust, secure archiving systems.

Transition and Implementation

Curious when your trials need to play by the new rules? If your initial application was submitted before the new regulations came into force in April 2026, you’re still operating under the previous framework—for now. However, any subsequent modifications will typically fall under the new procedures. That means sponsors may need to navigate both old and new legislation during this transitional phase, so planning ahead is key to staying compliant.

Florence: Your Trusted Partner in UK Compliance

At Florence, we’re committed to supporting clinical research teams throughout this regulatory shift. Our products are fully aligned with the latest legal requirements, helping sponsors and sites stay efficient, compliant, and audit-ready. Whether you’re launching your first UK trial or expanding operations, Florence is your trusted partner in navigating this evolving landscape. 

Contact us to learn more about digitising your trials while staying aligned with evolving regulations.