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Medicines: clinical trials hub

Legal framework, regulatory requirements, and supporting guidance needed to design, apply for, conduct, modify, close, and comply with UK legislation for clinical trials for medicines in the UK.

Updates to this page

From:
Medicines and Healthcare products Regulatory Agency
Published:
21 September 2023
Last updated:
28 April 2026
Show all updates

  1. This page has been updated to streamline and clarify information in light of recent changes to clinical trials legislation. Content has been reorganised, references updated, and links improved to direct users to current online guidance.

  2. Notification published of system updates and downtime, in preparation for the transition to the new Clinical Trials Regulations that are mandated on 28 April 2026.

  3. Added 'Clinical trials for medicines: guidance on quality and risk proportionality' and 'Clinical trials for medicines: guidance on compliance with ICH E6 good clinical practice (GCP) in the United Kingdom'.

  4. Added guidance document 'Clinical trials for medicines: good manufacturing practice and radiopharmaceutical investigational medicinal products'.

  5. Added 'International Council for Harmonisation (ICH) E6R3 Annotations'

  6. Added the following guidance pages to the collection: - Declaration of Helsinki and Clinical Trial Regulations alignment - Clinical Trials Regulations enforcement provisions - Archiving and retention of clinical trial records

  7. Added 'Common issues identified during clinical trial applications' to the group 'Guidance - before 28 April 2026'.

  8. Added link to payment DSU Payment centre to Pay an fees section of the collection.

  9. Added new page to collection: Route B substantial modification pilot

  10. Links added for draft guidance, to support amendments that come into force 28 April 2026.

  11. First published.

UK Legislation

The Medicines for Human Use (Clinical Trials)(Amendment) Regulations 2025 came into force 28 April 2026.

The Medicines for Human Use (Clinical Trials)Regulations 2004

The Medicines for Human Use (Clinical Trials)(Amendment) Regulations 2025

The Human Medicines Regulations 2012

Regulatory Framework

Important Note: This guidance is designed to assist sponsors and investigators in complying with their duties in relation to clinical trials. This page includes links to pages containing general guidance only. It must not be regarded as a definitive interpretation of the Regulations or a substitute for the regulations.

The MHRA cannot provide a definitive interpretation of the law; only the courts can do this. If in doubt you should seek your own legal advice.

International guidance

ICH Efficacy Guidelines

Other relevant guidance

Health Research Authority

MHRA guidance

The amended Clinical Trials Regulations took full effect on 28 April 2026. As such, this guidance should now be considered effective and is no longer in draft.

Applying for clinical trial approval

IMPs & NIMPs

During the clinical trial

Making changes to trials

Ending a trial

Compliance

News and blogs

Route B substantial modifications pilot: the results are in

MedRegs blog

Inspectorate blog

Payments and fees

Payments for DSUR submissions by credit or debit cards can be made via our payment centre.

Archived guidance

Access previous versions of MHRA Guidance from the UK Government Web Archive

Guidance - before 28 April 2026

Clinical Trials guidance that should be followed prior to 28 April 2026.

Contents

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