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Overcoming regulatory, pharmacovigilance, and market-access roadblocks to European expansion
What U.S. pharmaceutical companies need to know before launching in Europe's $488 billion market
Expanding into Europe offers life sciences companies access to a market of more than 740 million people and nearly one-third of global pharmaceutical sales — but commercial success requires navigating a regulatory and market-access landscape that is broader, more complex, and more interdependent than many sponsors anticipate.
Expanding into Europe offers life sciences companies access to a market of more than 740 million people and nearly one-third of global pharmaceutical sales — but commercial success requires navigating a regulatory and market-access landscape that is broader, more complex, and more interdependent than many sponsors anticipate.
This report outlines strategic and operational considerations and best practices that can help make the difference between success and failure for EU product launches.
You will discover:
- How the EU marketing authorization process differs from the FDA's — including the expanded obligations of the marketing authorization holder and the role of the EMA's centralized procedure
- What European pharmacovigilance requirements demand of sponsors before, during, and after marketing authorization, including the EU-QPPV designation, risk management plan, and pharmacovigilance system master file
- How 30 national Health Technology Assessment) HTA bodies assess pricing and reimbursement — and why a country-specific market-access strategy is essential to getting therapies into patients' hands
- How the EU's new Joint Clinical Assessment mandate and Most Favored Nation (MFN) pricing policies are creating a more globally interconnected pricing environment that affects U.S. reimbursement rates
- Why aligning regulatory, pharmacovigilance, and market-access strategies from the earliest stages of clinical development is the most effective way to reduce risk and accelerate global launch
Access the full Q2 2026 Industry Outlook Report today to build a more informed European expansion strategy.
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