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UK MHRA Guidance: UK Clinical Trials Regulatory Guidance – A Complete Overview (2026)

In the United Kingdom, the regulatory landscape operates under a well-defined set of guidance documents established and maintained by the UK Government and the Medicines and Healthcare products Regulatory Agency (MHRA). These documents help sponsors, regulatory affairs teams, and clinical operations professionals comply with UK law while ensuring patient safety and data integrity.


In 2026, several key guidances outline the authorisation process, trial notifications, reporting requirements, safety event handling, inclusion of in-vitro diagnostic devices, common application issues, enforcement expectations, and trial closure procedures.


This document explains how sponsors should apply to the MHRA for authorisation of a clinical trial in the UK. Authorization is required before clinical trials involving investigational medicinal products (IMPs) begin.

Key Points:

  • Trials involving unlicensed medicines or licensed medicines outside their current authorised use require formal MHRA approval.

  • The application must include:

    • A detailed protocol

    • Investigator’s brochure

    • IMP dossier

    • Safety monitoring plan

  • MHRA reviews applications to ensure risks to participants are minimised.

  • A valid UK Research Ethics Committee (REC) opinion must accompany the MHRA application before authorisation is granted.


Not all trials require full MHRA authorisation. Some trials can be conducted as notifiable trials.

What This Means:

  • Notifiable trials are generally low-risk studies using:

    • Licensed medicines within their approved use

    • Minimal changes unlikely to increase risk

  • These trials must still be notified to the MHRA, but do not require full authorisation.

  • Sponsors must provide essential information to the MHRA so it remains aware of the trial and can monitor compliance.


Once a clinical trial finishes, sponsors must follow specific procedures to notify regulators and close the study properly.

End-of-Trial Responsibilities:

  • Inform the MHRA and REC of the trial’s end date.

  • Provide a summary of results within required timelines.

  • Report serious safety events or trends that occurred during the trial.

  • Submit a final clinical study report as per regulatory timelines.


Trials involving in-vitro diagnostic devices (IVDs) require extra considerations because IVDs are regulated as medical devices in addition to the medicinal product.

Important Considerations:

  • Sponsors must comply with both medicines and medical device regulations.

  • IVD performance and safety data must be included in the clinical trial application.

  • Regulatory conformity (e.g., UKCA marking or equivalent) for the IVD must be considered if the device is used to determine dosing, safety, or clinical decision-making.


Handling safety events in clinical trials is critical for participant protection and regulatory compliance.

Core Obligations:

  • Sponsors must have systems in place to:

    • Collect safety data accurately

    • Verify event authenticity

    • Assess causality

    • Report serious events to MHRA

  • Timelines for reporting serious adverse events (SAEs) and suspected unexpected serious adverse reactions (SUSARs) are specified to ensure timely regulator awareness.


This guidance provides a checklist-style overview of frequent challenges and deficiencies observed in MHRA reviews of trial applications.

Examples of Issues:

  • Incomplete or inconsistent protocol information

  • Missing safety monitoring plans

  • Lack of clarity on IMP quality data

  • Insufficient justification for risk assessments

Understanding these common pitfalls helps sponsors prepare robust applications that minimise delays.


This guidance supplements the application process, providing step-by-step instructions for completing the UK submission.

Highlights Include:

  • Documentation requirements

  • Submission formats

  • Ethical approval timelines

  • Regulatory review expectations

This guidance ensures sponsors efficiently navigate MHRA requirements and REC coordination for approval.


Regulators reserve the right to enforce compliance with clinical trial regulations. This guidance outlines the legal authorities and consequences that can arise when sponsors fail to meet regulatory obligations.

Key Components:

  • MHRA powers to inspect trial sites and documentation

  • Corrective measures for non-compliance

  • Fines or sanctions where necessary

  • Responsibilities of sponsors, investigators, and site staff

Understanding enforcement provisions helps stakeholders proactively design compliant processes and avoid regulatory action.


The UK clinical trial regulatory framework is structured to ensure participant safety, data integrity, and scientific rigour. Sponsors and regulatory professionals must align with all applicable guidance to navigate approvals smoothly, protect participants, and uphold data quality.

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The views expressed in this publication do not necessarily reflect the views of any guidance of government, health authority, it's purely my understanding. This Blog/Web Site is made available by a regulatory professional, is for educational purposes only as well as to give you general information and a general understanding of the pharmaceutical regulations, and not to provide specific regulatory advice. By using this blog site you understand that there is no client relationship between you and the Blog/Web Site publisher. The Blog/Web Site should not be used as a substitute for competent pharma regulatory advice and you should discuss from an authenticated regulatory professional in your state.  We have made every reasonable effort to present accurate information on our website; however, we are not responsible for any of the results you experience while visiting our website and request to use official websites.

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