Článek

An EU perspective on traversing the new transatlantic pharmaceutical partnership

Rob Worsley

Shifting EU-U.S. partnership places emphasis on strategic management of the development, regulatory, manufacturing, and supply chain continuum

For many years, the European pharmaceutical sector has benefited from the United States serving as a primary financial and regulatory anchor for global drug development. Europe’s focus has long been on ensuring patient access to affordable medicines that address unmet medical need, alongside objectives relating to innovation and long-term sustainability of healthcare systems.

Meanwhile, the U.S. market’s scale, research and development investment, and rapid adoption rates have historically helped fuel the innovation reaching patients in Europe.¹

This dynamic will continue to evolve throughout 2026, shifting the industry toward a state of heightened strategic vigilance. The current changes in U.S. market dynamics represent a unique moment for European regulators, policymakers, and pharmaceutical companies to adopt more active strategic management of the development, regulatory, manufacturing, and supply chain continuum.

The shifting landscape heightens the need for growth and resilience, supported by partnerships and internal optimizations that can help to secure Europe’s future in a changing global landscape while supporting efforts by both U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) to work toward greater regulatory convergence despite evolving economic and policy pressures.

The transition to the Office of Inspections and Investigations

The reorganization of FDA field operations offers clear evidence of a strategic shift. In late 2024, the Office of Regulatory Affairs (ORA) was replaced with the Office of Inspections and Investigations (OII), marking a pivot toward more risk-based global inspection model.^2,3 In 2025, the FDA expanded its unannounced inspection pilot to include the European Union (EU), leading to verification audits of German and Irish facilities without notifying local authorities. This reflects the FDA’s stated move toward a more risk based global inspection model, with greater emphasis on direct verification of compliance at foreign manufacturing sites.⁴

The following data illustrates the results of this intensified posture:

Metric	FY 2024 (Baseline)	FY 2025-On (Current Data)
Foreign Warning Letters	245	412 (as of Dec 2025)
Official Action Indicated (OAI) classifications	~7% of foreign sites	~24% of foreign sites
Untitled letters	5	58

Reference:
These figures are derived from publicly available FDA enforcement and compliance datasets and reflect GMP‑related actions associated with foreign manufacturing sites, primarily within CDER‑regulated product areas. Figures are presented for illustrative trend analysis rather than as a comprehensive enforcement accounting.

A 73% increase in warning letters indicates a fundamental change in the regulatory environment. As a result, companies must find ways to align their quality systems with these new, more stringent OII expectations before an inspector arrives. Addressing compliance concerns requires a proactive strategy that translates these shifting U.S. requirements into actionable site readiness.

The economic interdependence of global R&D

A central reality of the biopharmaceutical industry is that U.S. revenue often offsets the lower profit margins accepted in European single-payer systems. The U.S. market historically accounts for nearly half of global revenue, supporting the capital risks involved in drug discovery.^5,2 However, this balance is increasingly strained by a combination of policy‑driven pressures on U.S. purchasing power, including renewed tariff exposure for branded pharmaceuticals, uncertainty created by Most‑Favored‑Nation–style pricing initiatives, reductions and delays in National Institutes of Health (NIH) research funding, and recent regulatory volatility at the FDA, including refusals to file or delayed reviews for certain mRNA‑based vaccine applications.

When U.S. margins shrink, organizations frequently prioritize profit by rationalizing their R&D programs. The U.S. Inflation Reduction Act (IRA) has introduced price-negotiation eligibility timelines rather than limiting exclusivity.⁶ For European firms, this creates a viability risk for high-stakes small molecule projects in areas like neuroscience or rare diseases.⁷ Companies need to navigate these economic headwinds by leveraging granular market access insights that can help to keep a product commercially sustainable even as global pricing models shift.

Technical divergence and the two-trial reality

We are seeing regulatory standards that are now evolving in different trajectories, The FDA increasingly utilizes accelerated approvals based on biomarkers, such as amyloid plaque reduction in Alzheimer’s.⁷ Meanwhile, the EMA maintains a strict focus on definitive clinical outcomes, often rejecting datasets that lack proven functional benefits for the patient.^8,9 Nevertheless, it is important to emphasize that both agencies continue to use flexible approval pathways, despite differences in timing, evidence thresholds, and tolerance for uncertainty at approval.

This creates a complex environment where trials need to account for increasingly complex evidence-generation strategies within a global program, including adaptive designs, staggered filings, and region-specific endpoints. Companies must often choose between a faster, biomarker-driven path for the U.S. or a longer, outcome-focused study for Europe.¹⁰ This duplication adds significant cost and delays. To bridge this gap, companies can consider hybrid protocols that capture surrogate data for the FDA while maintaining the blinding necessary to gather the long-term results demanded by the EMA.

Strengthening supply chain resilience through strategic coordination

While EU institutions and national governments pursue the objective of strategic autonomy, the industry continues to benefit from a deep integration with U.S. technical infrastructure.¹¹ The specialized tools required for biotechnology, such as single-use bioreactor bags and purification resins, are largely supplied and operationally controlled by U.S. life science companies.¹² Purification resins used in biologics manufacturing are similarly supplied by a concentrated set of global vendors, including U.S.‑headquartered companies.¹³ As the U.S. enhances its focus on domestic supply security, European manufacturers have a clear opportunity to refine their procurement and logistics strategies to prevent potential bottlenecks or tariff impacts.¹⁴

Since the process of qualifying new suppliers requires extensive re-validation, companies are finding success by navigating existing trade frameworks with greater precision and working with partners that have sophisticated logistics capabilities to manage these evolving requirements effectively. Manufacturing centers in Europe need to ensure complex trade compliance and the secure transport of high-value reagents to maintain consistent and uninterrupted operations. Despite divergence in certain areas, the broader framework of transatlantic regulatory cooperation currently remains strong and continues to support alignment on core scientific and quality principles.¹⁵

Advancing the industry through strategic alliances

The changing landscape of the cross-Atlantic partnership serves as a powerful catalyst for building more resilient and sophisticated systems that account for divergence in certain areas despite a strong commitment to transatlantic regulatory coordination. As the industry enters an era where traditional global optimization is being enhanced by a vital need for specialized and local expertise, there is a need to adopt a more robust approach to how life-changing medicines are developed and delivered.

In this new environment, the most successful organizations will be those that leverage expert partnerships to harmonize divergent regulatory and economic realities into a single and successful commercial strategy.

*Zdroje pokračují níže

About the author:

Rob Worsley is an Associate Director in CMC regulatory affairs with over 15 years of pharmaceutical industry experience, specializing in global CMC strategy, regulatory submissions, and lifecycle management. He brings deep technical expertise across GMP, quality, and R&D, supporting products from early clinical development through to commercial readiness and post‑approval change. Rob is highly experienced in cross‑functional and CDMO coordination, regulatory authority interactions, and technical authorship across complex development and manufacturing environments.

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Informace uvedené v tomto článku nepředstavují právní radu. Společnost Cencora, Inc. důrazně doporučuje čtenářům, aby si prostudovali dostupné informace týkající se probíraných témat a při rozhodování s nimi se spoléhali na vlastní zkušenosti a odborné znalosti.

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