Europe is emerging as an attractive route to global market access for Chinese sponsors. Early consideration of EMA requirements can help avoid costly delays and improve approval success. Read the article: https://ow.ly...
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EU PPWR’s Two-Role Split Creates Costly Compliance Trap For Device Makers
The EU PPWR separates packaging compliance into two distinct roles — manufacturer and producer — with very different obligations. Conflating them is the most common error seen.
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What medtech makers need to know about the EU’s new packaging rules
The European PPWR comes into force in August 2026. ICON's contributing authors provide their perspective on the impact and what Sponsors need to consider as a result of the new rules for Med Devices.
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Why Europe, not America, may be Chinese sponsors’ smartest move
As Chinese sponsors expand globally, Europe offers a stable, science-driven regulatory environment and broad market access across the region. Planning for EMA requirements from the outset helps accelerate approvals, minimise costly study adaptations and support long-term commercial success.
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Real-World Evidence in transition: CRO adaptation to the European Health Data Space framework
This article explores how the European Health Data Space (EHDS) is transforming real-world evidence generation by shifting CROs from data custodians to regulated data users operating within secure, interoperable environments, creating new opportunities for pan-European research while requiring greater investment in compliance, data standardisation and methodological rigour.
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Navigating the Risks and Rewards of Biomarker-Based Surrogates and Accelerated Approval
Examine how accelerated approvals can unlock earlier market access and why weak biomarker foundations, self-competitive confirmatory trials and payer misalignment remain critical risks.
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It’s complicated! When APAC global ambition meets regulatory reality
While not all sponsors plan to market treatments beyond the country of origin, many do. Those sponsors with global ambitions must decide which regulatory route offers the most strategic advantages and which market, particularly between the EU and US.
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June 2026 Medical/ Commercial Pulse Check
With the first EU JCAs finalized and CMS extending deadlines for its ambitious Medicaid international-pricing model, ICON and other industry leaders share how they are navigating the friction between global harmonization and local execution including the practical evolution of global pricing floors, the maturing role of AI agents, and the new reality of European access.
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Biosimilar Success in an Evolving Landscape: Development Considerations for Staying Competitive
Regulatory pathways for biosimilars are changing, with reduced clinical requirements placing greater emphasis on analytical comparability and manufacturing excellence. Understanding how to respond to these shifts can make the difference between speed to market and costly delays. Explore the key considerations shaping today’s biosimilars landscape in ICON's latest article.
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Integrated by Design. Strategic pathways for drug-led combination products
Combination products, which integrate a drug and/or biologic component with a medical device component, are increasing globally. Because they do not fit neatly into a single category, regulation of these products can be difficult to navigate.
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Faster Doesn’t Mean Easier: Development Impacts of a New Biosimilar Regulatory Landscape
Regulatory authorities have made it clear that streamlining biosimilar development is a priority, following the example of the EMA and FDA in reducing the requirements for comparative efficacy studies. Read this article to understand the recent changes and their impact.
