The UK Clinical Trial Regulations are changing

New UK Clinical Trial Regulations, approved in April 2025, will come into force on 28th April 2026. These regulations, which amend the previous 2024 law, will simplify processes, increase flexibility, and emphasise transparency and patient centricity. Key changes include a legam requirement to register trials in a WHO recognised register, publish results summaries within 12 months, and offer trial findings to participants. The Medicines and Healthcare products Regulatory Agency (MHRA) have developed these changes in collaboration with the Health research Authority (HRA) to foster innovation and maintain the UK's competitive advantage in clinical Research.

The UK Clinical Trials Regulations were initially published as a Statutory Instrument (SI) – a UK law-making procedure – as SI 2004 No.1031, and came into force on 1 May 2004.
Since then, numerous SIs have modified the original Regulations, largely due to the introduction of a new EU Directive and subsequently the EU Clinical Trial Regulation No. 536/2014.

Following the UK’s withdrawal from the EU, further changes to the UK Clinical Trials Regulations were necessary.
These are detailed in The Medicines for Human Use (Clinical Trials) (Amendment) (EU Exit) Regulations 2019 (SI 2019 No. 744). More recently, revisions to the Declaration of Helsinki in 2024 and to the International Council for Harmonisation E6(R3) Guideline on GCP in 2025 have inevitably impacted the way in which trials are performed globally, including in the UK.

A new system of approval in the UK and ways to make the UK a more attractive place for performing clinical trials have led to further amendments to the UK Clinical Trials Regulations.

On 12 December 2024, The Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025 were laid before the UK Parliament, marking a significant update to the regulation of clinical trials in the UK. The new Regulations come into effect on 28 April 2026, following a 12-month implementation period.

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