MRHA publishes raft of guidance on new UK Clinical Trial Regulations
21 Jan 2026
5 min read
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The MHRA have published a series of announcements to help Life Sciences companies interpret the new UK Clinical Trial Regulations (the Regulations). The Regulations, which come into force on 28 April 2026, form part of a set of reforms which government hopes will help to bring increased research, clinical trials and new medicines to the UK.
You can read more about how the Regulations will change the current UK clinical trials regime in our previous blog post.
The recent announcements include:
- New application processes aimed at increasing the UK's competitiveness for global clinical research;
- Information on enforcement provisions, offences and compliance requirements for sponsors and investigators under the Regulations;
- Information on clinical trial record retention and archiving requirements under the Regulations;
- Guidance on the alignment between of the Declaration of Helsinki and the Regulations; and
- Information to help comply with International Council for Harmonisation (ICH) E6R3 for those running clinical trials in the UK.
We have compiled a summary of these announcements below.
Improving the UK's competitiveness for global clinical research
Recent figures show there was a rise in clinical trial applications in 2025, with growth strongest in early and innovative research. Compared to 2024, there was a 7% rise in trials being run in the UK for the first time which. MHRA say this reflects growing international confidence and they predict a greater increase following the introduction of the Regulations.
The MHRA highlighted the following changes under the Regulations which will increase the UK's competitiveness in global clinical research:
- The introduction of a fast-track notification route allowing lower-risk trials to start sooner whilst maintaining high safety standards. This will free up experts to focus on complex and early phase studies;
- The introduction of a 14-day assessment route for phase 1 trials;
- Supporting clearer and more agile routes to support innovation by enabling better use of early safety data from overseas studies that comply with UK Standards;
- new MHRA capability to assess computer model simulations to predict how medicines may behave.
Guidance on significant additions to Regulations enforcement provisions
The amended Regulations broaden the provisions that can trigger an infringement notice (Regulation 48) or constitute an offence (Regulation 49).
The MHRA guidance outlines two significant additions:
- Accuracy in Notifications and Requests - sponsors and applicants need to ensure that notifications of important details or modification requests to MHRA or ethics committees must be accurate, or action may be taken against them; and
- The creation of new offences associated with:
- Non-investigational medicinal products;
- Breaches of the notification scheme;
- Failures in record keeping for serious adverse events and reactions;
- Non-compliance with transparency requirements; and
- Lapse of clinical trial approval.
Guidance on archiving and retention of clinical trial records
The guidance outlines the responsibilities for archiving and retaining clinical trial records to ensure compliance with Good Clinical Practice (GCP) and regulatory requirements. The Regulations introduce updates to archiving and retention requirements for clinical trial records:
- The definition of 'essential records' has been updated in line with ICH GCP E6 (R3) which emphasises the documentation of metadata, audit trails, and digital records to ensure completeness and traceability;
- The minimum retention time for Trial Master Files (TMF) and associated essential documents will increase from 5 years to 25 years; and
- Reinforcing Data Integrity Standards by highlighting that records must be complete, legible, readily retrievable, and securely stored to maintain integrity throughout the retention period.
Transitional Provisions – Old Rules vs New Rules
Trials where the application was submitted before 28 April 2026 (Old Rules Clinical Trials) need to follow old regulation 31A(7 & 7A) for archiving obligations.
The TMF must be retained for at least 5 years after trial conclusion and must remain complete, legible, and readily available to the licensing authority. If the trial data supports a UK marketing authorisation, essential records must be retained for 2 years after the authorisation is granted. Medical records must comply with new regulation 31A(8) being retained for a minimum of 25 years after trial conclusion.
Trials where the application was submitted on or after 28 April 2026 (New Rule Clinic Trials) must comply with updated regulation 31A(7, 7A & 8) as outlined above.
For all trials, documentation relating to an authorised product must be retained for as long as the product remains authorised and the final clinical study report must be retained for 5 years after the product is no longer authorised.
Guidance on the alignment of the Declaration of Helsinki and UK Clinical Trial Regulations
The Declaration of Helsinki (the 'Declaration') sets internationally recognised ethical standards for medical research involving human participants' and its principles' must be complied with unless they contravene the requirements of the Regulations.
The guidance highlights three key areas where the Declaration and the Regulations do not align:
Key Areas of Divergence between the Declaration and the Regulations | |||
| Declaration | Regulations | Practical Implications | |
| Placebo Use | Permits placebo use only under strict conditions (e.g. no proven intervention exists) | Greater flexibility to use placebos, allowing use even when effective treatments exist, provided the trial is scientifically robust, ethically approved, and maintains a favourable risk–benefit profile. | Sponsors must justify their approach and ensure transparency |
| Urgent Safety Measures | Ethical committee oversight needed before making changes to the trial | Urgent safety actions permitted without prior ethics approval | Sponsors must document decisions and notify regulators promptly |
| Post-Trial Access | Requires arrangements for post-trial access to beneficial interventions | No statutory requirement: decisions should be made on case-by-case with clear internal rationale | Must ensure that there is a record of internal rationale |
Sponsors should aim to comply with the Declaration and the Regulations, but where compliance with the Declaration would undermine safeguards under the Regulations or operational feasibility, MHRA expects sponsors to prioritise compliance with UK law while recording the rationale for deviations from the Declaration.
Guidance on compliance with International Council for Harmonisation (ICH) E6R3
ICH E6(R3) references 'applicable regulatory requirements' in various places. The new guidance specifies what the applicable regulatory requirements or relevant guidance documents reference in ICH E6(R3) are for the UK. For more detailed information you can read the guidance here.
The MRHA hopes that the new Regulations and associated reforms will help to deliver the Life Sciences Sector Plan, by allowing greater flexibility for clinical trials and aligning the UK regulatory framework more closely with the EU.
If you would like to discuss any of the above, please contact a member of our Health, Care and Life Sciences Team.
This article was written by Ishbel McCormack and Rory Trust