On 28 April 2025, the United Kingdom Parliament and Northern Ireland Assembly approved The Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025, (the “New Regulations”) the most significant UK clinical trial regulations update in over two decades. The New Regulations introduce changes to the Medicines for Human Use (Clinical Trials) Regulations 2004. They go into effect 28 April 2026 and will bring the UK into line with the position in the EU.
Because these regulations will apply to all clinical trials in the UK, it is important that critical trial sponsors familiarize themselves with these changes and begin preparing accordingly to ensure compliance by April 2026.
Overview of the New Regulations
The goal of the New Regulations is to modernize the clinical trial process in the UK. The New Regulations aim to accomplish this by streamlining the general process and easing administrative burdens while maintaining rigorous clinical trial regulations. This is generally reflected in an updated approval process for clinical trials, simplified arrangements for consent, and updated template documents.
In addition, the New Regulations also introduce changes to existing legislation in order to make the legislation compliant with Good Clinical Practice (GCP) International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) guidelines.
Impact on Sponsors and Compliance
Because of the broad scope of updates and changes featured in the New Regulations, the NHS HRA has made available guidance to help sponsors to comply. Of note is the NHS HRA “Guidance on changes to clinical trials regulations” which sponsors should read to fully understand the changes coming into effect. To better assist sponsors in preparing for the New Regulations, we have prepared an overview of some of the major changes that pertain to sponsor compliance.
1. Definitions and Terminology
The New Regulations introduce three new definitions (“non-investigational medicinal product”, “notifiable trial”, and “public registry”) in addition to updating the definitions of multiple existing terms. Notably, “subject” will be replaced by “participant” and “trial site” will be replaced by “trial location”. Finally, “modification” will be used instead of “amendment” when referring to changes to approved trials.
2. Research Transparency Requirements
Sponsors of clinical trials involving investigational medicinal products (CTIMPs) should take note of these new transparency requirements to maintain sponsor compliance:
- Register the clinical trial in a public registry before the recruitment of the first participant or within 90 days of approval of the clinical trial (whichever is sooner).
- When the trial has concluded, a summary of the results must be published within 12 months.
- Offer to share a summary of the results with participants or relevant individuals in a format and manner that participants, or those who provided consent on their behalf, can readily understand.
Failure to follow these requirements will constitute an offense and may result in the Medicines and Healthcare Products Regulatory Agency (MHRA) taking action against the sponsor.
3. Approval Process for Clinical Trials
To further support innovation, the New Regulations introduce a refined approval process with shorter timeframes during the review. Notably, the new term “notifiable trial” applies in this context and refers to a trial with no significant safety concerns related to any of the investigational medicinal products, making it eligible for expedited approval.
4. Simplified Arrangements for Consent in Clinical Trials
Sponsors of clinical trials that meet certain criteria will have the option to use simplified arrangements for seeking and evidencing informed consent. To be eligible, the trial will need to meet the following conditions and detail them in the protocol:
- The investigational medicinal product(s) is authorized for use in the UK and is used in accordance with that authorization.
- The investigational medicinal product(s) is given to the participant as part of the participant’s routine health care.
- The participant receives no additional medication, diagnostic procedure, or medical intervention for the purposes of the clinical trial.
In addition, the sponsor needs to provide the reason for obtaining consent using a simplified arrangement, the information that will be provided to the participant and how it will be made available, and the means by which consent will be evidenced.
5. Pharmacovigilance
Under the 2004 Regulations suspected unexpected serious adverse reactions (SUSARs) and annual safety reports for CTIMPs are submitted to both the MHRA and Research Ethics Committee (REC). The New Regulations aim to simplify the process for sponsors by requiring SUSARs to be reported only to the MHRA, which then determines whether any ethical issues require review by the REC.
The New Regulations also increase the amount of time sponsors have to give written notice to the MHRA and REC for an urgent safety measure from three calendar days to seven calendar days. The process otherwise remains the same.
Updated Templates and Guidance
On 1 April 2025, the NHS published a new GDPR transparency wording template to ensure that research participants have all the information they need to make an informed decision about the use of their data. Effective immediately with the publication of the template on 1 April 2025, applications submitted by sponsors must either feature the GDPR transparency wording template or, if the sponsor chooses to have their own language, demonstrate how their bespoke wording meets the four principles for meaningful involvement of patients and the public in health and social care research.
At the end of April 2025, the NHS released updated model agreements, notably the Model Clinical Trial Agreement and Model Commercial Chief Investigator Agreement. These changes are part of a broader effort to have an efficient and streamlined UK commercial contracting process and the new model versions must be used without modification.
While sponsors are responsible for using the appropriate documents when preparing their research applications, the NHS HRA provides resources and the necessary templates through the Integrated Research Application System (IRAS).
Practical Steps for Sponsors
As previously noted, sponsors should look to the guidance prepared by the NHS HRA to ensure that they fully understand the changes and scope of the New Regulations. Sponsors should also take the time to ensure staff are aware of the New Regulations and the 28 April 2026 effective date. All clinical trials taking place in the UK will need to comply with the updated regulations and sponsors should be working on a transition plan in advance of April 2026 to avoid compliance issues.
In planning for the transition, sponsors should be aware that, while the GCP ICH guidelines requirement is effective 28 April 2026, the change will apply to all CTIMPs, regardless of whether they were submitted before or after the date.
Conclusion
The New Regulations are an important, and welcome, development for UK clinical trial regulation. The changes to the regulations should simplify the application process for sponsors and the adoption of GCP ICH guidelines is critical as it brings the UK in-step with EU clinical trial regulation. If they have not already, sponsors should take a proactive approach to the New Regulations and work to ensure that they are prepared and in compliance by 28 April 2026. VeraSafe has deep expertise in guiding clinical trial sponsors through UK regulatory requirements and is well-positioned to help organizations quickly understand and adapt to these new changes.
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