The first significant overhaul of the UK clinical trials regime in two decades begins to take shape

In brief:

On 12 December 2024, draft legislation to amend the Medicines for Human Use (Clinical Trials) Regulations 2004 was laid before Parliament, marking the start of the first significant overhaul of the UK clinical trials regime in two decades.

The draft Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2024 (draft Regulations) will be debated this year and are expected to come into force in early 2026.

The new draft legislation follows a period of consultation by the MHRA, and the publication by the UK government of its response to consultation in March 2023 (see our previous blogs here and here). The update comes against a backdrop of increasing interest in UK clinical trials, as highlighted in a recent report by the ABPI. 

In detail:

The updates proposed by the draft Regulations are intended to support more streamlined regulation of clinical trials and remove unnecessary administrative burdens on clinical trial sponsors, whilst at the same time protecting the interests of clinical trial participants. The draft Regulations intend to:

• ensure patients’ safety is at the centre of all clinical trials; 
• create a proportionate, flexible and streamlined regulatory environment that is agile and responsive to innovation; and
• cement the UK as a destination for international trials, bringing the UK clinical trials regime into closer alignment with the EU clinical trials regime. 

Some of the key proposals relate to:

• Transparency: Clinical trial sponsors would be required to register trials in a World Health Organization-recognised public register, and to publish a summary of results within 12 months of the end of the trial. 
• Streamlining: The draft regulations provide for a streamlined application procedure for the authorisation to conduct the clinical trial and the application for ethics committee opinion. The draft regulations also include the ability to use simplified means of seeking and recording consent in clinical trials for medicines with a lower risk profile (for example, trials involving medicines that have already been approved). 
• Research Ethics Committees: The draft regulations propose to move away from setting out specific requirements for the constitution of Research Ethics Committees towards more general principles aligned with international good clinical practice standards ICH-GCP E6.
• Record keeping: It will be a requirement to retain the medical files of trial participants for 25 years (as opposed to five years currently).

The government intends to publish guidance to sit alongside the new legislation, covering matters such as good practice in clinical trials, diversity and inclusion, and involvement of members of the public in the design, and conduct and dissemination of research.

What happens next?

As mentioned, the draft legislation will be debated in Parliament in 2025, and we expect to see some further amendments to the text. The amended Regulations are then expected to come into force in early 2026.

To discuss the proposed changes in more detail, please reach out to one of the authors.