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Proposed Legislative Changes for UK Clinical Trials

Proposed Legislative Changes for UK Clinical Trials

Are changes coming to new clinical trials in the UK?

On 17th January 2022, the United Kingdom (UK) Medicines and Healthcare products Regulatory Agency (MHRA) issued proposals to revise the current Medicines for Human Use (Clinical Trials) Regulations 2004 with the aim of improving and strengthening clinical trials regulation in the UK.1

The proposals have been developed by the MHRA and Health Research Authority (HRA), in collaboration with an Expert Working Group of stakeholders from across the clinical research sector, including patient representation. Further, the proposals as issued are open for public consultation until 14th March 2022 and, consequently, the timeline for implementation of these proposals remains unknown at this time.

The underlying rationale for the proposed revisions is to create a “world-class sovereign regulatory environment for clinical trials” with the UK now more than one year on from leaving the European Union following the conclusion of Brexit.

Key objectives for the proposed revisions2

  • Promote public health and ensure protection of participants remains at the heart of legislation
  • Remove obstacles to innovation whilst maintaining robust oversight of the safety of trials
  • Streamline the regulation of clinical trials and reduce unnecessary burden to those running trials by embedding risk proportionality into the framework
  • Facilitate the evaluation and development of new or better medicines to reduce the burden of disease on patients and society
  • Ensure the legislation builds international interoperability so that the UK remains a preferred site to conduct multi-national trials

At present the Medicines for Human Use (Clinical Trials) Regulations 2004, as amended, transpose the requirements of the EU Clinical Trials Directive 2001/20/EC into UK law. Consequently, the EU Clinical Trials Directive will be retired on 31st January 2025 following implementation of the EU Clinical Trials Regulation (Regulation (EU) 536/2014) on 31st January 2022.

The proposed revisions of the current UK regulations for clinical trials focus on the following key areas:

  • Patient and public involvement
  • Safety reporting
  • Research transparency
  • Good Clinical Practice
  • Clinical trial approval processes
  • Sanctions and corrective measures
  • Research Ethics review
  • Manufacturing and assembly
  • Informed consent in cluster trials
  • Definitions and other terminologies



The proposed revisions to the UK regulatory framework for the approval and conduct of clinical trials are far ranging and will—to a certain extent—enshrine current working practices of the UK MHRA and RECs.

It is notable that the proposed revisions to the review and approval process may further streamline the time taken to attain approvals to initiate a study. Equally notable is that there is an emerging divergence from the framework adopted by the European Union with its implementation of the Clinical Trials Regulation.


1. MHRA, Clinical Trials and Investigations, Open Consultation.

2. MHRA, Consultation on Proposals for Legislative Changes for Clinical Trials.

3. MHRA, Annex A – Legal basis and the assessment of the matters set out in section 2 of the Medicines and Medical Devices Act 2021.