What Sponsors Need to Know About UK Combined Review 2026

UK Combined Review is now embedded in legislation, changing how sponsors seek regulatory and ethics approval for clinical trials of investigational medicinal products (CTIMPs).

The model brings the MHRA and Research Ethics Committee (REC) review into a single application and coordinated decision process, creating a more integrated route from protocol development to trial start.

Image

UK Combined Review: One Application, Two Reviews

Combined Review is not new with the Health Research Authority (HRA) and MHRA having used the approach since 2022, but the 2026 clinical trial regulations formally place it into the UK regulatory framework.

The amended regulations came into force on 28 April 2026.

As part of Combined Review, sponsors submit a single application through the new part of  the Integrated Research Application System (IRAS).

The application goes to the MHRA and an REC at the same time. Where relevant, it also supports study-wide review for NHS or Northern Ireland Health and Social Care settings. 

The important operational shift is coordination. Regulatory and ethics reviews run in parallel, while requests for further information can be consolidated.

Sponsors then provide a response through the system rather than managing disconnected review processes. 

This matters because regulatory strategy and trial operations are becoming harder to separate.

Protocol design, supporting documentation, ethics considerations, and regulatory evidence must work together from the outset.

Read Maximise Pharma Innovation With Quality-by-Design

Maximise Pharma Innovation With Quality-by-Design

Find out how Quality-by-Design improves reliability and compliance in pharma and how you can maximise innovation through quality-based pharma development systems.

New Submissions Timelines Change Sponsor Planning

The revised process establishes clearer statutory expectations.

For a valid initial application, the MHRA or REC will issue a final decision or request further information within a maximum of 30 calendar days. If further information is requested, sponsors have up to 60 calendar days to respond.

Following a response, the final outcome is generally issued within a maximum of 10 calendar days. 

Independent expert advice can extend these periods. For example, an initial review can extend by up to 90 additional calendar days where specialist advice is required. Advanced therapy medicinal products can create additional time requirements at the response stage.

However, faster review does not mean less preparation.

A poorly coordinated submission can still generate questions, delay the decision, and consume valuable development time.

The advantages of Combined Review therefore depend partly on submission quality.

Image

What Does UK Combined Review Change for Clinical Trial Sponsors?

The new clinical trial regulatory reforms go beyond the application itself.

The regulations introduce clearer categories for modifications, including substantial modifications, modifications of an important detail, and minor modifications. They also introduce or update terminology across the framework. 

The reforms also create a new expectation around trial activation.

Approved clinical trials of investigational medicinal products (CTIMPs) are expected to recruit their first UK participant within two years, unless an extension applies. If recruitment does not begin within that period and no extension is granted, approval can lapse.

That connects approval directly to operational execution.

Sponsors therefore need to consider whether their site strategy, recruitment planning, supply readiness, and study start-up infrastructure can support the approved timeline.

The HRA’s updated IRAS process also supports applications and modifications through the life of the trial. 

Pharmatica’s analysis of U.S. Food and Drug Administration (FDA) oncology trial eligibility guidance similarly shows how regulatory changes increasingly affect practical trial design and recruitment.

Similarly, our analysis discusses how the FDA has changed expectations around one or two pivotal trials required for approval, and the EU efforts to streamline regional clinical trial approval.

Transparency Is a Clinical Trial Regulatory Requirement

The UK 2026 clinical trial reforms also strengthen transparency.

For new-rule trials, UK law now requires medicinal-product clinical trials to be registered in a public registry and requires a summary of results to be published within 12 months of completion.

Sponsors must also offer participants an accessible summary of results. Deferrals are available in specific circumstances. 

This shifts transparency from a good-practice principle towards a defined regulatory responsibility.

It also increases the importance of data governance. Trial teams need systems capable of maintaining accurate records, supporting reporting obligations, and preserving evidence throughout the study lifecycle.

What UK Combined Review Means for Pharma

The significance of UK Combined Review is not simply that sponsors complete fewer forms. It represents a broader move towards a more integrated clinical trial operating model.

The UK is attempting to make approval more coordinated while maintaining separate scientific and ethical scrutiny.

For sponsors, that creates an opportunity to reduce duplication, but it also raises the importance of submission quality and cross-functional preparation.

The wider 2026 UK clinical trial regulatory reforms also introduce proportionate approaches to areas such as informed consent, transparency, pharmacovigilance, and research ethics.

Combined Review should therefore be treated as part of the trial strategy, not merely an administrative submission route.

At Pharmatica, we analyse how regulatory change affects the practical mechanics of pharmaceutical development. Our Insights connect policy, clinical operations, technology, and commercial strategy so decision-makers can understand what regulatory reform means beyond the legislation.

Pharmatica: Insight. Connection. Impact.

Image