Supporting innovation, increasing transparency and prioritising efficiency - what to expect from the UK's new clinical trials regulatory framework

What is the aim of the new framework?

The MHRA and the Health Research Authority (HRA) have worked together to significantly update the UK's clinical trial regime, with the aim of accelerating approvals and providing a proportionate and flexible framework to encourage research and innovation. This stands to support the UK government's Life Sciences Sector Plan (published in July 2025) - which views strengthening the UK's clinical trials ecosystem as a key ingredient to making the UK attractive to develop and deploy new treatments and technologies.

When is this coming in?

The amended Medicines for Human Use (Clinical Trials) Regulations 2004 (Clinical Trials Regulations) will be effective from 28 April 2026. Please be aware that you may have seen that the amended regulations were due to come into force on 10 April - this date was later revised due to a technical issue on the final processing of the relevant statutory instrument.

What are the key changes?

• Fast-track notification route 

As part of its commitment to a streamlined, risk-proportionate approach to reviewing applications, lower risk clinical trials that meet certain criteria will be categorised by the licensing authority as "notifiable" - and applications for these trials will be granted automatic authorisation. In its recent press release, the MHRA has estimated that around one in five studies will be on this route - allowing many lower risk trials to begin quicker and enable the MHRA to focus on reviewing more complex applications. One of things emphasised in the UK government's Life Sciences Sector Plan is risk-proportionate regulation. This is new notification route is a clear example of how the MHRA will be implementing this approach in practice. 

The definition of "notifiable" is set out in a new Regulation 11A. Applicants will need to meet certain criteria (including there being no significant safety concerns and the participants not falling into higher risk groups such as children) and one of three specific conditions (Conditions A, B or C). Condition C, in particular, is interesting - this is that the clinical trial that has been assessed and approved by the relevant licensing authority in the EU, an EEA State or the USA. This is very much in keeping with international regulators' efforts to harmonise and standardise applications, processes and approvals - and we can expect to see more of this approach in future regulatory changes. As discussed in its Life Sciences Sector Plan, the UK government is keen to use international reliance and recognition routes for medicines and medical devices so that products can reach the market more quickly and in a risk-proportionate way. A key step in this plan is a new pre-market statutory instrument for medical devices, including an International Reliance Framework, which is scheduled to be introduced to Parliament by Autumn 2026.

Applicants should be aware that there is discretion to undertake a full review even if the trial meets the eligibility criteria. There are also certain "additional criteria" that have been set out in the MHRA's draft guidance as having potential to increase risk surrounding the trial. If any of these additional criteria apply, the draft guidance states that this should be made clear in the cover letter.

Applicants will still need to factor in some time after making the notification before they can begin with their trial. The application will be subject to the same validation checks that apply for non-notifiable trials and the trial cannot process until the applicant receives a combined decision that the trial is approved (or approved with conditions). The process for ethics committee review for notifiable trials will also be the same as that for non-notifiable trials – so, the initial combined decision can be expected within 30 calendar days of validation. The MHRA has published a helpful flow chart showing the process and timescales.

• More transparency

Over the past 10 years, there has been much discussion around transparency in clinical trials - in particular, increasing transparency around failures, so that others can build on previous research and ultimately bring benefit to patients. Regulation 25 deals with new transparency requirements. Clinical trials will need to be registered in a public registry by the date on which the first participant signs their consent form or within 90 days after the date of approval for the clinical trial (whichever is earlier). A summary of the results must be published in the same registry as the trial was registered within 12 months of the trial ending, and participants will also need to be offered a summary written in a form that is accessible to a lay person. The wealth of data that the new transparency requirements will unlock, coupled with AI capabilities, will hopefully allow researchers to progress and discard approaches more quickly, and increase the speed with which new products and treatments can get to market.

Sponsors may apply to the HRA for a deferral or waiver of the transparency requirements before the relevant 12-months deadline. However, the Clinical Trials Regulations (as amended) specify that waivers may only be made in exceptional circumstances – i.e. if this is necessary for reasons of national defence and security.

Organisations need to set up a system to carefully monitor and comply with these requirements - particularly as the Clinical Trials Regulations (as amended) state that any failure to comply (which has not been rectified) is a factor that a licensing authority may have regard to when assessing future applications.

• Greater enforcement powers

Under the amended Clinical Trials Regulations, there are greater enforcement provisions for the MHRA. There is an expanded list of provisions against which an infringement notice may be issued (Regulation 48) or an offence raised (Regulation 49). There are also some new offences. For example, sponsors and applicants may now face action if notifications of important details or modification requests contain false or misleading information (see Regulation 50). It is important that organisations and their senior management and key personnel are aware of the new offences, so that they can implement new controls and processes, as appropriate.

• Retention

There have been some changes to archiving requirements for trial records. In particular, the minimum retention time for Trial Master Files (TMF) and participant medical files has been increased from 5 years - now, these documents will need to be retained for at least 25 years beginning from the date of conclusion of the trial (or longer if needed for marketing authorisation purposes) (see Regulation 31A). Sponsors and applicants will need to amend their data retention and archiving policies and systems to ensure compliance with this.

• Interaction with international texts 

The MHRA has also shown a desire to maintain harmony with international texts:

The Declaration of Helsinki

The Declaration of Helsinki (Declaration) establishes internationally recognised ethical standards for research involving human participants. The MHRA has stated in its draft guidance that the Declaration is to be complied with, but has identified that there are certain areas of the amended Clinical Trials Regulations which may come into conflict with it - for example, the new framework allows some flexibility in terms of how placebos are used. Part 2 of Schedule 1 to the amended Clinical Trials Regulations sets out that sponsors must comply with the principles of the Declaration when undertaking trials unless there is any conflict with the requirements of the amended Clinical Trials Regulations. The MHRA clarifies in its draft guidance that if there is any deviation, the reasoning for this should be documented.

ICH E6(R3)

The MHRA is now a full member of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) - an international collaborative network for sharing and implementation of best practices across member regions. ICH's Guideline for Good Clinical Practice (the latest version being ICH E6(R3)) is an international guideline developed with the aim of facilitating harmonisation in respect of quality of clinical trial conduct. ICH E6(R3) will be implemented in the UK and the MHRA has published draft guidance to set out the UK-specific annotations that apply under the amended Clinical Trials Regulations.

What should your business be doing to prepare?

• The MHRA has published draft guidance on its Clinical Trials Hub, which has been referred to through this article. The regulator has said that only minimal adjustments will be made prior to 28 April 2026, so it is a good idea to read through this and start making plans for implementing changes. In particular, it will be crucial to review the guidance for Good Clinical Practice (GCP) when this comes out - the last MHRA update on this at the time of writing was that this will be published in January 2026.
• Ensure that your organisation is clear in its understanding of what has changed and any new requirements. We can provide a review of the changes and the key action points, if you would like support with this.
• Review your organisation's clinical trial agreements and associated agreements with third parties to ensure that your organisation can comply with its obligations under the amended regulatory framework. As an example, ensure that any licensed record management system providers are aware of the extended document retention period and can comply with this. We can support with reviewing relevant agreements, so please contact us if you have any queries.
• Consider reaching out to the MHRA for scientific advice when designing a clinical trial to ensure compliance and make the process more efficient. Early input from the MHRA may also prevent delays later on.

This is an evolving situation. The above information is based on the draft MHRA guidance as at the time of writing, but please check the Clinical Trials Hub and our website for further updates.

As discussed in this article, the amended Clinical Trials Regulations will play an important role in bringing to life key elements of the UK government's Life Sciences Sector Plan. At our 2026 PING Conference, we will be exploring what the plan means in practice, with perspectives from industry experts and leaders. Please see further details here. 

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If you have any thoughts about how the upcoming regulatory changes may affect businesses, or if you need any support understanding the changes or would like us to review your organisation's clinical trials agreements or associated agreements, please contact Emily Dyer in our Pharmaceuticals and Life Sciences team.