Medicines Marketing UK / EU vs US: Why Your Launch Strategy Needs a Continental Divide - Dr Lisa Campbell, Director of Regulatory Strategy

A UK CRO’s perspective on planning clinical trials for global success

For pharmaceutical companies preparing for global expansion, launching in both the US and EU / UK  markets often seems like the natural next step. Yet success in one region does not guarantee success in the other. While regulators may share high-level principles, the US, EU, and UK operate under different systems with distinct expectations for clinical evidence, timelines, and commercial readiness.

As a UK-based contract research organisation (CRO), we help sponsors design and deliver trials that anticipate these differences. Clinical programmes must do more than meet regulatory standards - they must generate the ‘right data for the right market at the right time’. Regulatory harmonisation remains a goal, but region-specific strategies are essential for successful product launch.

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US Launch: Speed, Scale, and Real-World Evidence

The US remains the world’s largest and most commercially attractive market for new medicines. Its regulatory framework, led by the Food and Drug Administration (FDA), offers streamlined and well-defined pathways such as the New Drug Application (NDA) and Biologics License Application (BLA).

The FDA places strong emphasis on clinical efficacy and safety and offers fast-track mechanisms that can bring therapies to market at pace—particularly for high unmet need areas. This flexibility extends beyond approval: medicines can often begin generating revenue while further data is collected through real-world evidence or post-marketing studies.

From a clinical trial perspective, sponsors aiming for the US typically focus on:

• Early FDA engagement to align on endpoints and study design

• Robust efficacy and safety data from pivotal trials  

• Real-world evidence strategies to support broader adoption post-launch

• Digital health data and outcomes that strengthen payer conversations

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Speed and prescriber engagement are central to US commercial success. Trials must be designed not just to satisfy regulators, but to enable downstream market entry and reimbursement.

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EU Launch: Regulatory Rigour and Reimbursement Complexity

In contrast, launching in the European Union presents a more complex path. While the European Medicines Agency (EMA) provides a centralised approval route, access to patients is ultimately decided country by country through individual health technology assessment (HTA) processes, pricing negotiations, and local reimbursement decisions.  The new EU Health Technology Assessment (HTA) Regulation (EU 2021/2282), which came into full effect on 12 January 2025, marks a major shift in how health technologies—particularly medicines—are evaluated across Europe. It introduces a Joint Clinical Assessment (JCA) process designed to streamline and harmonize evaluations across member states.  As of January 2025, JCA’s apply to new cancer medicines and Advanced Therapy Medicinal Products.

Each member state evaluates medicines against its own criteria. For example:

• Germany’s G-BA may require comparative effectiveness data and economic modelling

• France’s HAS values real-world outcomes and quality-of-life measures

• Spain’s regional authorities expect budget impact analyses and often prefer established distribution networks

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From a clinical development perspective, this fragmentation means that EMA authorisation alone is insufficient. Trials must be designed to generate evidence that satisfies both central regulators and local payers.

Critical elements include:

• Comparator selection that reflects local standard of care

• Patient-reported outcomes relevant to national value assessments

• Subgroup analyses that support regional reimbursement arguments

• Language- and country-specific adaptations for later value dossiers

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UK Trials: A Distinctive Gateway with Global Relevance

Since leaving the EU, the UK has emerged as a standalone regulatory environment. The Medicines and Healthcare products Regulatory Agency (MHRA) now operates independently from the EMA, but remains scientifically aligned with both the EMA and FDA.

For sponsors, this presents both challenges and opportunities. The UK offers:

• Expedited regulatory timelines, often more agile than the EU

• A highly integrated NHS, enabling efficient recruitment and long-term follow-up

• Access to real-world data through electronic health records and linked datasets

• A favourable environment for early-phase and adaptive trial designs

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Moreover, the UK’s Innovative Licensing and Access Pathway (ILAP) supports faster approval and early patient access for promising new therapies. NICE (the UP payer) is involved much earlier in the drug development process, helping shape evidence generation and value propositions.

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When designing UK trials, sponsors should consider:

• NICE-specific evidence needs, including health economic models and QALYs

• Alignment with MHRA through scientific advice, particularly for novel therapies

• Utilising NHS infrastructure for pragmatic, real-world relevant designs

• Global relevance of UK data, which is still widely accepted by both the EMA and FDA

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UK trials can generate data that serves multiple markets, while benefiting from a well-established research ecosystem and regulatory flexibility.

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Strategic Implications: Three Systems, Three Mindsets

Understanding the commercial landscape informs how trials should be designed and sequenced:

In the US:

• Launch nationally, build prescriber and payer engagement

• Real-world evidence strengthens market position post-approval

• Speed to market can provide first-mover advantage

In the EU:

• Secure reimbursement before widespread uptake

• HTA and pricing approvals vary by country

• Tailored evidence and local engagement are essential

In the UK:

• Independent but globally aligned

• Efficient regulatory pathways and integrated healthcare system

• Real-world data generation and cost-effectiveness evidence matter

Each market demands its own strategy beginning at the clinical development stage. Trial design, endpoint selection, and site strategy must reflect these diverging regulatory and commercial priorities.

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What Medicine Sponsors Should Do Early

To avoid costly delays and duplication of effort, sponsors should:

1. Design Trials with Global Goals: Incorporate endpoints relevant to FDA, EMA, MHRA, and HTA expectations. Include health outcomes, economic data, and utility measures from the outset.

2. Run Regulatory Pathways in Parallel: Plan for concurrent interactions with the FDA, EMA, and MHRA. Harmonise core data packages while accounting for regional variations in reporting and documentation.

3. Build Market Access into Study Protocols: Clinical programmes should support pricing and reimbursement as well as approval. Select comparators carefully, include resource use data, and ensure follow-up captures real-world effectiveness.

4. Think National, Act Local: Localise evidence and engagement strategies. Develop value dossiers tailored to national payer priorities. Engage country-specific KOLs, advocacy groups, and clinical leaders early.

Planning Trials That Launch Globally

As a UK CRO, we specialise in delivering trials that support global ambitions while accounting for regional complexities. From protocol development to data delivery, our focus is on building flexible, rigorous programmes that accelerate both regulatory approval and market access.

The earlier you align your clinical strategy with your launch goals, the stronger your position across the US, EU, and UK.

In today’s fragmented but interconnected markets, medicines don’t just need to be safe and effective, they need to be strategically positioned. And that begins at the trial stage.

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About the Author

Dr Lisa Campbell – Director of Regulatory Strategy, Richmond Pharmacology

Dr Lisa Campbell leads Regulatory Strategy at Richmond Pharmacology, where she oversees early engagement with the MHRA, EMA, and FDA to align clinical trial designs with regulatory and market access requirements. With more than two decades of experience spanning both global pharmaceutical companies and CROs, Lisa has a deep understanding of how clinical programmes must adapt across jurisdictions. She specialises in designing regulatory roadmaps that anticipate regional complexity. helping sponsors achieve approvals faster and with greater clarity.

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