One Strategy, Two Jurisdictions: Unlocking Efficiency Across EU CTR and UK Regulatory Reform

1. The Regulatory Landscape: A Window of Opportunity

Both the EU and UK currently have a modern, streamlined clinical trial framework, and together they create a uniquely favorable environment for sponsors planning to perform clinical trials across both jurisdictions.

In the EU, Regulation No. 536/2014 (EU CTR)¹ has been fully in force for new and legacy trials since January 2025, replacing the patchwork of national requirements that previously made multi-country studies slow and costly. Through the Clinical Trials Information System (CTIS), sponsors can now submit a single application covering all participating EEA (European Economic Area: EU, Iceland, Liechtenstein and Norway) Member States, representing a significant simplification for multinational trials.

In the UK, the Medicines for Human Use Clinical Trials Regulations 2025² came into force on April 28, 2026, completing the most significant overhaul of UK clinical trial rules in two decades.^3,4 The headline result for sponsors: significantly faster MHRA approval timelines, with a clear government target to reduce total trial set-up time to 150 days.

The practical upshot is that EU and UK submissions, while legally independent, can be run in parallel with a high degree of shared infrastructure and documentation. Sponsors who understand this are gaining a meaningful competitive advantage over those who treat the two jurisdictions as alternatives.

2. Obtaining Efficiencies: The EU-UK Dual-Track Advantage

A common perception is that running EU and UK trials simultaneously doubles costs. In practice, a well-designed dual-track strategy shares a substantial proportion of the operational infrastructure, reducing marginal costs and improving efficiency.

2.1 Single Protocol with Regional Addenda: One Medical and CMC Writing Effort

Both EU CTR 536/2014 and the UK’s amended regulations are grounded in ICH GCP (E6 R3) and share a broadly aligned clinical documentation framework. A single, ICH-compliant protocol can serve as the core document for both submissions.

This approach yields direct savings across:

• Clinical Protocol: One core document with eventual regional addenda.
• Investigator’s Brochure (IB): A single core IB with shared Reference Safety Information (RSI)⁵ recognizing that minor jurisdiction-specific adaptations may be required.
• Investigational Medicinal Product Dossier (IMPD): a largely unified IMPD, with targeted adjustments for region-specific requirements.

2.2 Combined Site Start-Up Workstreams: Parallel Execution

While the CTIS submission (EU) and the IRAS/Combined Review submission (UK) are legally separate processes with independent timelines, there is no regulatory barrier to preparing and executing them in parallel.

A well-resourced SSU (Study Start-Up) team can achieve different efficiencies:

• Preparation of a single adaptable core dossier.
• Conducting feasibility and site selection concurrently.
• Deploying harmonized training materials with local adaptations.
• Negotiating aligned contractual structures across regions.

2.3 Leveraging Overlapping Standard of Care

Clinical practice across the EU and the UK is broadly comparable, supported by shared scientific guidance and similar treatment frameworks. Study design elements, including eligibility criteria, endpoints, and background therapies are typically transferable with minimal modification.

2.4 Central Oversight Functions

Sponsors can consolidate key central functions such as pharmacovigilance, medical monitoring, and data management across both regions.

Despite separate submission pathways, the alignment in regulatory expectations allows the implementation of asingle global oversight model, reducing duplication while maintaining compliance.

3. Strategic Advantages of Running Both EU and UK

Beyond cost efficiency, running a dual EU+UK program delivers strategic advantages that extend across the entire lifecycle of a development program.

3.1 Faster Startup and First Patient In: With MHRA Leading the Way

This advantage is increasingly reflected in publicly reported performance metrics. The MHRA’s accelerated timelines mean that UK approvals rather often are completed while EU Member State review processes are still ongoing.

Sponsors who commence UK SSU activities in parallel, rather than sequentially after EU approval, can achieve measurable acceleration in First Patient In (FPI), typically in the range of several weeks depending on study complexity.⁶

Under the UK 2025 regulations’ notification scheme, low-risk trials with prior EU or US authorization may be only notified to the MHRA rather than requiring full review, potentially further reducing UK entry requirements.

Beyond regulatory approval, the UK Government targets a total trial set-up time of 150 days, with the HRA reporting high compliance with the 60-day approval target and median Research Ethics Committee timelines of approximately 29 days.^7,8

In contrast, the EU CTR establishes harmonized statutory timelines across member states. Following validation, the coordinated scientific assessment (Part I) is conducted within a maximum of 45 days, with possible extensions in case of Requests for Information or complex study designs.

While these timelines provide predictability, the multi-state coordination inherent to CTIS introduces variability in practice, driven by:

• the number of member states involved
• study complexity
• the timing and scope of RFIs (Request for Information)

For sponsors, this creates a genuine “fast entry” opportunity: UK sites can open and begin screening while EU CTIS review is still underway. However, the EU CTIS has launched a recent initiative which started in January 2026, whereby the EU has established an accelerated review process, FAST-EU (Facilitating and Accelerating Strategic Trials), as a pilot program, aiming to facilitate a maximum overall timeline of 70 calendar days from CTIS submission to final conclusions, including sponsor response times.

This represents a significant reduction of more than 30 days from the standard maximum.

3.2 Strengthened Regulatory Position

When a Marketing Authorization Application (MAA) is filed, a development program that contains robust data from both the EU and the UK jurisdictions is materially stronger than an MAA anchored only in a single geography. EMA scientific committees and the MHRA each weigh on the quality of the clinical evidence base, a dataset reflecting site diversity, patient population breadth, and dual-regulatory oversight, which signals that the program has been stress-tested across complementary but distinct regulatory environments and jurisdictions.

3.3 Patient Population Diversity and Site Resilience

The EU provides access to a large and diverse population across multiple member states, while the UK offers a highly integrated healthcare system with efficient patient identification and recruitment pathways. Combining both regions enhances recruitment performance, supports obtaining broader data sets, and introduces resilience: delays in one region do not halt the entire program.

4. Operational Considerations and Limitations

While the dual EU+UK model provides clear advantages, it also introduces additional complexity that must be actively managed.

Regulatory divergence

Although aligned, the systems are independent. Differences in regulatory queries, document expectations, and post-authorization obligations may arise between the two jurisdictions, requiring jurisdiction-specific responses and careful coordination to avoid inconsistencies in the overall regulatory record.

Parallel governance demands

Managing two concurrent regulatory pathways increases demands on document control, regulatory coordination, and decision-making timelines. Effective execution typically requires a strong central governance structure at the sponsor and/or CRO levels.

Effective dual-track governance typically requires:

• A designated dual-jurisdiction regulatory lead with authority to prioritize and arbitrate across both submission streams.
• A single source-of-truth document management system that clearly tags jurisdiction-specific versions and prevents unauthorized local edits.
• Regular cross-functional project meetings, typically weekly during active submission and review phases, that include regulatory, medical, operations, and data management representatives.

Upfront investment

Dual-track strategies may involve higher initial resource requirements, particularly during protocol development and submission preparation, even if efficiencies are realized later.

The initial cost premium is typically recovered through faster FPI, higher enrollment rates from a larger site network, and the avoidance of a sequential second-region start-up.

Variability within the EU process

Despite harmonized timelines, practical variability remains within the EU due to multi-state coordination and iterative review cycles.

Key sources include RMS selection, since the reviewing authority’s culture and workload affect effective timelines; the scope and timing of RFIs, which can extend Part I review; and Part II national divergence, where local ethics and site suitability assessments remain subject to less fully harmonized national procedures.

Implications for Sponsors

The aforementioned operational considerations do not necessarily undermine the strategic case for dual-track development, but they do define the conditions under which it succeeds. Programs that realize the full benefits of the EU+UK model are those in which complexity is anticipated, governance is established early, and the regulatory and operational teams are resourced for sustained parallel execution.

The dual-track approach should therefore be viewed not as a simplification, but as a strategic model requiring appropriate planning, resourcing, and execution.

5. Conclusions

Together, the EU Clinical Trial Regulation and the UK reformed network, define a dual-track environment in which a single, well-designed program can access the regulatory strengths of both jurisdictions. Sponsors who plan to implement their clinical trials in the EU and UK as soon as possible starting from the protocol design stage, sharing documentation, shared oversight and site start-up activities, will achieve the cost efficiency of a single-region program while capturing the strategic and commercial advantages of both.

5.1 Seven Steps to Get Started

• Design the protocol from day 1 for dual submission.
• Align IB and RSI update strategies across both jurisdictions.
• Submit CTIS and IRAS applications in parallel.
• Assess eligibility for MHRA notification pathways.
• Negotiate vendor contracts with combined EU+UK scope.
• Implement a single central safety function.
• Use UK site activation to accelerate early recruitment where feasible.

In an era of increasing global competition for clinical trial sites, patients, and investment, the dual EU+UK model is not merely an option worth considering. It is swiftly becoming the standard for strategic planning for pharma and biotechs development programs with high commercial ambitions in either or both markets.

About the Author

Eva Font, Start-up and Regulatory Director – Pivotal.

References

1. European Parliament and Council. Regulation (EU) No 536/2014 of the European Parliament and of the Council on Clinical Trials on Medicinal Products for Human Use. Official Journal of the European Union. Published May 27, 2014.

2. UK Parliament. Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025. SI 2025/538. Published April 2025.

3. Health Research Authority. New UK clinical trials regulations signed into law, implementation period begins. HRA News. Published April 2025.

4. Health Research Authority; Medicines and Healthcare products Regulatory Agency. Guidance on changes to the clinical trials regulations. HRA/MHRA. Updated October 2025.

5. European Medicines Agency. Questions and answers on the EU clinical trials regulation: Q&A document v7.2. EMA. Published March 2026.

6. MHRA Inspectorate. Clinical trials regulations: six-month countdown begins. MHRA Inspectorate Blog. Published October 28, 2025.

7. Health Research Authority. HRA Strategy 2025–2028. HRA; 2025.

8. UK Department of Health and Social Care. Government drives forward its 150-day clinical trial target - GOV.UK Published April 15, 2026.