Update to UK Clinical Trials Regulation: New Retention Rules to Come into Effect in 2026

Update to UK Clinical Trials Regulation: New Retention Rules to Come into Effect in 2026

The UK’s clinical research landscape is undergoing its most significant regulatory transformation in two decades, with the new UK Clinical Trials Regulation signed into law on the 11^th April 2025. The new regulation, created by the MHRA in collaboration with the HRA (and taking on feedback from patients and industry) will come into effect on the 10^th April 2026 after a 12-month rollout period.

The new regulations bring sweeping changes into effect, aiming at “…strengthening patient safety, accelerating approvals, enabling innovation and helping more people benefit from taking part in vital research.”

If you are interested in the full list of changes, you can find them on the official UK government website.

For the purposes of this article, I want to focus on what the regulations say to the long-term retention of clinical records and data. So let’s look at these in more detail…

How long does the MHRA require sponsors to retain clinical trial records?

The new UK Clinical Trial Regulation brings in the extension of the mandatory minimum retention period for clinical trial master files (TMF) and associated records from 5 years to 25 years. This applies to all documents, including those in electronic form, beginning from the day after the conclusion of the trial.

Additionally, “If, at the date of the expiry of the 25 years…the data generated by the trial is being used to support an application for a UK marketing authorization, the sponsor shall ensure the documents…are retained for at least the period of 2 years beginning with the day after the grant of that UK marketing authorization.”

This largely brings the new regulation in line with EU CTR, requiring sponsors to ensure that the TMF is accessible, available and legible for at least 25 years. If you’re interested in finding out more about how to comply with the retention requirements of EU CTR, we published a blog post last year on the Six critical eTMF retention requirements: complying with EU Clinical Trial Regulation.

MHRA alignment with ICH E6(R3)

The new regulation has also explicitly added the reference to;

“The conditions and principles of good clinical practice include those in the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use Guideline for Good Clinical Practice, as amended from time to time.”

Given that ICH E6(R3) is the ICH’s good clinical practice (GCP) guidelines, it’s inclusion means that the MHRA are in effect mandating it’s use within the new regulation. This is a further alignment of UK clinical trials with the EU/EMA, firstly both mandating a 25-year retention period, and now both follow ICH E6(R3).

If you would like to read more about these guidelines, we recently published an eBook on what the recent update to ICH E6 had to say for long-term data retention.

A risk-proportionate clinical trials system

MHRA Chief Executive Lawrence Tallon has described the new regulation as “a key step towards a stronger, more responsive and risk-proportionate clinical trials system that works better for patients.”

The new framework introduces a more flexible, risk-proportionate approach. This means that while oversight remains robust, lower-risk trials may benefit from reduced bureaucratic burdens, reducing the time to market for some drugs.

That said, good clinical practice must still be adhered to across a trial, including the following of good documentation practices and record keeping. This should include adopting a risk-based approach to long-term data management; understanding what data must be retained, how long for, associated risks to data integrity for that given period and appropriate actions to mitigate those risks.

Operational considerations for sponsors, CROs and sites

While many organisations will have already adapted their processes in line with EU CTR and ICH E6(R3), it is worth sharing some operational considerations for organisations who have yet to make the change;

• Fit for purpose archives: Organisations must assess their long-term digital repositories to ensure compliance with the 25-year retention rule; including ongoing data integrity checks, long-term digital preservation and safeguarding measures.
• Avoid vendor lock-in: Ensure data is not locked in proprietary or end of life systems. 25 years is a long time for software and hardware applications and it is important to ensure essential data is accessible and portable. If not, it can put that data at risk and be costly to resolve.
• Policy and SOP Revisions: Standard operating procedures (SOPs) and data management policies must be updated to reflect the new timelines and requirements, ensuring all teams understand the extended obligations.

Conclusion

The MHRA’s new clinical trials regulations marks a further shift in how long-term clinical trial records and data must be managed. Clinical organisations in the UK (and those who operate within the UK market) must act to align their systems and processes to meet the new 25-year retention requirement and ensure compliance ahead of the April 2026 deadline.