2025 promises to be a year of further advancements in the UK’s life sciences sector and one important area of on-going development is the regulation of clinical trials.
After some delay, the much anticipated Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2024 (the new Regulations) were laid before Parliament on 12 December 2024, intended to amend the current UK framework governing clinical trials. This has been described as the “biggest overhaul of the clinical trial regulations in 20 years”, and is intended to cement the UK as a worldclass destination for conducting international clinical trials, to “support [a] more streamlined and flexible regulation of clinical trials, removing unnecessary administrative burdens on trial sponsors, whilst protecting the interests of trial participants.”
Key changes proposed by the new Regulations are discussed below. While certain regulatory requirements will be set out in the legislation, the aim is to move away from a “one-size-fits-all” approach, allowing for a more proactive response to innovation. This is in line with the new streamlined notification scheme for lowest risk clinical trials, which the MHRA introduced in October 2023, as discussed in our previous blog post. As such, the new Regulations have been described as “as future-proof as possible and […] responsive to different types of trials and innovative ways of carrying out trials.”
The new Regulation will be debated in Parliament in early 2025 and, after a 12 month implementation period, the aim is for the new Regulations to come into force in early 2026. In addition, guidance, which is already under development, will be used for specific details, rather than the new Regulations being too granular and prescriptive. The aim is for the guidance to become ‘live’ in January 2026, to coincide with the new Regulations.
Key changes
We set out below key changes of interest in the new Regulations and that were discussed by the MHRA during its recent webinar (though these are by no means a complete overview). Many of the proposals were also set out in the consultation on the proposed revisions, to which the Government published its consultation outcome on 21 March 2023, as set out in our previous blog post.
Approval process
The new Regulations aim to streamline the approval of clinical trial applications through embedding a single application route into UK legislation for the first time (though this approach has been available for some time through various schemes and pilots). This consists of a combined regulatory (MHRA) and research ethics committee (REC) review, leading to a single UK decision for a clinical trial. The application will be made through the Integrated Research Application System (IRAS).
Timelines have been updated, with a combined decision on an application being issued within 30 calendar days following validation (which takes up to 7 calendar days). Further, if requests for further information are made by the MHRA/REC following their review, the applicant will have 60 days to respond, and a decision will be available within 10 calendar days following receipt of the response(s). These timeframes are intended to promote competitiveness and flexibility in the application and approval process. Readers will be aware that there has been substantial focus on the MHRA approval times for clinical trials, and this has been a critical area for which the MHRA has been seeking to demonstrate that it can meet, and better, statutory timelines. The shorter statutory timelines will be welcomed by industry – if they are consistently met by the authorities.
Under the new Regulations, the option for making separate submissions will be available in exceptional circumstances, including where independent expert evidence is required. Furthermore, if consultation with committees or specialist groups on an application is required, timeframes will be extended.
A notification scheme for low-intervention/ lower-risk clinical trials will be introduced under the new Regulations, allowing sponsors to notify the MHRA about eligible clinical trials where the risk to participants is similar to standard medical care (as noted above, an initial notification scheme has been in place since October 2023 for eligible Phase 3 and Phase 4 trials). The notification scheme is intended to allow notifiable trials to be approved without the need for full regulatory assessment, cutting down the time it will take for these trials to become operational, without compromising patient safety (note that the scheme relates to regulatory approvals only; REC approval is required as per non-notifiable trials).
Subject to options on extensions, the approval of a trial will lapse at the end of 24 months beginning with the date of approval, if there are no participants recruited to take part in the trial.
Research transparency
The new Regulations require clinical trials to be registered on a public registry (which means a primary or partner registry of, or a data provider to, the WHO International Clinical Trials Registry Platform) by the earlier of either the date on which the first participant is recruited or 90 days after the date of approval. Further, the sponsor will be required to publish a summary of results on the same public registry within 12 months of the trial ending and it will be a regulatory requirement to offer to share a summary of results with participants in a suitable format, in a way that is understandable to laypersons. Certain waivers or deferrals may be available for these requirements, depending on the circumstances.
Readers will be aware that transparency is a key focus of changes introduced in the EU under the Clinical Trials Regulation 536/2014/EU. The UK has chosen to adopt some of these provisions, but has not gone as far as the EU legislation. While there has been talk of the UK joining the EU CTIS platform, this is not set out in the new Regulations.
Good clinical practice
Compliance with the overarching principles of good clinical practice (GCP) in order to align with the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) guidelines will be a requirement, establishing compliance with international standards. However, compliance with the entirety of the guidelines will not become a legal requirement in the UK (although may in practice been necessary if the data generated from the trial will be used in other countries).
From 26 May to 31 August 2023, the MHRA ran a public consultation on the revised ICH guidance on GCP; the MHRA confirms that feedback is still being analysed. In addition, on 15 November 2024, the MHRA launched a further consultation on Annex 2 (relating to additional considerations for non-traditional interventional clinical trials) to the ICH Guidelines; this consultation is due to close on 14 February 2025.
Manufacturing and assembly
The new Regulations include a definition of ‘non-investigational medicinal product’ (NIMP), as “a medicinal product used or to be used in a clinical trial, as described in the protocol, but not as an investigational medicinal product”. Including the definition in the legislation, rather than in the guidance as it is currently, aims to provide assurance in relation to the quality and safety of these products. Certain requirements will apply to these products, including compliance with GMP and certain labelling requirements. There will also be greater flexibility to the requirements for labelling of licensed medicinal products used in clinical trials, where this is considered appropriate.
Safety reporting and pharmacovigilance
The intention is to remove safety reporting requirements that are duplicative and do not further contribute to the monitoring of patient safety. This includes removal of the requirement to list serious adverse events and serious adverse reactions in annual safety reports and instead, an appropriate discussion will be included on how safety concerns have been evaluated and interpreted. This is not intended to reduce the focus on safety of participants, but to ensure that the reporting obligations are proportionate to the risk.
Guidance
The production of supplementary guidance to the new Regulations is already in progress and will cover the following topics:
- Requesting approval for a clinical trial
- Modification to a clinical trial approval
- Notifiable trials and the notification scheme
- Safety
- Research transparency
- Simplified means of seeking and recording consent
- Ending a clinical trial
The Health Research Authority (HRA), with whom the MHRA has worked closely throughout this process, is leading the development of guidance specifically on research and transparency, as well as on the simplified means of seeking and recording consent. The HRA will also be producing guidance on inclusion and representation and public involvement in clinical trials (for which it has recently been seeking views from stakeholders), which were proposals that have not been included in the new Regulations.
The MHRA and HRA have adopted a five-step approach to preparing the above guidance, as follows:
- drafting the guidance (on-going)
- engagement with stakeholders (November 2024 – March 2025)
- publication of final draft guidance (March – April 2025)
- obtaining further comments on final draft guidance (April – June 2025)
- final version of adopted guidance to be issued (August 2025)