On 28 April 2026, the UK introduced one of the most significant reforms to its clinical trial framework in more than 20 years. The Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025 introduce major changes to how trials are approved, managed, and reported, with direct implications for how sponsors plan and execute investigational medicinal product (IMP) supply strategies.

For pharmaceutical companies, biotech organisations, and academic researchers conducting trials in the UK, understanding these reforms is essential for maintaining compliance and operational readiness. This article outlines the key regulatory developments and explores their practical implications for IMP supply and clinical trial operations.

What Is Changing

Combined Review becomes a statutory process

The Combined Review process, which enables sponsors to submit a single application covering both MHRA regulatory approval and Research Ethics Committee (REC) review, has operated in practice since 2022. Under the updated regulations, this coordinated approach is now formally embedded within the UK clinical trial framework.

For sponsors, this means one integrated application process, one coordinated review pathway, and a more streamlined route to trial approval.

Streamlined pathways for lower-risk trials

The updated framework introduces notification-style pathways for certain lower-risk clinical trials and modifications, applying a more proportionate regulatory approach where appropriate.

Government and industry commentary has suggested that a proportion of lower-risk studies may qualify for these streamlined routes, potentially reducing timelines between application and study activation. For IMP supply teams, this increases the importance of operational readiness and responsive supply planning.

14-day assessment pathway for certain Phase 1 trials

The MHRA has introduced a 14-day assessment pathway for eligible Phase 1 clinical trials using a stepwise review approach. The aim is to strengthen the UK’s attractiveness for early-phase research and improve the speed of study initiation.

In practice, shorter approval timelines may place additional pressure on IMP manufacturing, packaging, labelling, QP certification, and distribution activities.

New transparency obligations

The updated regulations introduce enhanced transparency requirements for UK clinical trials. Sponsors are expected to:

• register trials on a recognised public registry within the required regulatory timelines
• publish a summary of trial results within 12 months of trial completion
• provide trial results to participants in accessible, understandable language where appropriate

These measures are intended to improve public trust, participant engagement, and access to clinical research information.

Updated terminology and modification categories

The regulations replace the term “subject” with “participant” to better reflect the voluntary nature of clinical trial involvement.

The term “amendment” is also replaced with “modification”, with modifications categorised according to regulatory significance, including:

• substantial modifications (Route A or Route B)
• modifications of important detail
• minor modifications

Although primarily administrative, these terminology changes may affect SOPs, labelling documentation, quality systems, and internal processes across clinical supply operations.

What This Means for IMP Supply

A central theme of the 2026 reforms is greater efficiency in clinical trial approvals and oversight. However, accelerated regulatory timelines only support faster study initiation when operational planning and IMP supply activities are equally prepared.

Sponsors that establish IMP supply strategies early in the approval process may be better positioned to support compressed study start-up timelines. Delays in manufacturing, packaging, labelling, or distribution may affect overall programme readiness.

Practical considerations for sponsors may include:

• initiating IMP manufacturing and packaging activities earlier where appropriate
• preparing compliant labelling templates in advance of approval
• ensuring QP certification processes can support accelerated timelines
• building flexibility into distribution planning for rapidly activated studies
• updating SOPs and documentation to reflect revised terminology and modification categories

How IPS Pharma Supports Sponsors

IPS Pharma provides integrated clinical trial supply services covering sourcing, manufacturing, blinding, labelling, QP certification, storage, and distribution.

This coordinated approach is designed to support sponsors managing complex or time-sensitive supply requirements under the updated regulatory environment.

IPS Pharma’s QP services and technical consultancy teams can also support sponsors with IMPD review and CTA preparation.

For sponsors requiring comparator sourcing alongside IMP supply, IPS Pharma’s global sourcing network supports access to generics, biosimilars, rescue medications, and adjuvant therapies.

Benefits and Considerations for UK Participants

Potential Benefits

• More efficient regulatory pathways may help reduce the time between trial approval and patient recruitment
• Public registry requirements may improve transparency and accessibility of clinical trial information
• Participant-facing result summaries may improve communication and engagement with trial participants

Considerations

• Sponsors and research sites may require time to fully implement updated processes and systems
• Participants should continue to verify trial legitimacy using recognised public registries and official channels

Finding and Participating in UK Clinical Trials

Useful resources for identifying UK clinical trials include:

• NIHR Be Part of Research
• ClinicalTrials.gov
• EU Clinical Trials Register
• ISRCTN Registry

How to Verify Clinical Trial Legitimacy

Patients and participants should consider the following when reviewing clinical trials:

• confirm the study is listed on a recognised public registry
• verify that the trial has appropriate MHRA authorisation where required
• confirm that a favourable REC opinion has been granted
• ensure IMP has undergone QP certification in accordance with applicable UK requirements

External Resources

Useful sources of further information include:

• MHRA — Clinical trials for medicines: apply for approval in the UK
• HRA — Clinical Trials Regulations Reform
• GOV.UK — UK boosts clinical trials attractiveness

Disclaimer

This article is intended for informational purposes only and does not constitute legal or regulatory advice. Sponsors should consult current MHRA and HRA guidance when planning or conducting clinical trials in the UK.