Overcoming Regulatory, Pharmacovigilance, And Market Access Roadblocks To European Expansion

European pharmaceutical sales exceeded $488 billion in 2024 and are projected to surpass $688 billion by 2030, representing nearly one-third of global pharma revenue. For U.S.-based sponsors, that opportunity comes with real complexity. Marketing authorization in the EU requires establishing a legal entity, designating an EU-qualified person for pharmacovigilance, and satisfying 30 separate HTA bodies, each with distinct evidence standards. Most-favored-nation pricing policies now link European price negotiations directly to U.S. reimbursement rates, raising the strategic stakes further. Add mandatory joint clinical assessments for oncology and advanced therapy products since January 2025, and the case for integrating regulatory, pharmacovigilance, and market-access planning from day one becomes clear.

Read the full report to understand what a global-first launch strategy requires before your next development milestone.