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Pharmaceuticals

Combination Products: Navigating Regulatory Landscapes Across EU, US and China

Wednesday, May 6, 2026
14:30 - 15:30 WEST
Location: Auditorium 3
Learning Level: Advanced
Description: The regulation of combination products - therapeutic or diagnostic products combining drugs, devices, and/or biological components - is one of the most complex areas in global healthcare oversight. The primary challenges involve navigating regulatory non-harmonization, classification and jurisdictional ambiguity, technical and clinical evaluation complexity, and quality alignment. How do global regulations in major markets for drug-led or device-led combination products compare? Do China or US regulations align with European regulatory frameworks or what are the gaps?

This session will explore these and other questions relating to the complex and evolving area of combination product regulation, with a focus across the 3 major markets of Europe, US and China. First, the core regulatory frameworks for drug-led and device-led combination products in each of the core markets of Europe, China and the US will be briefly presented. Then the panelists will share practical experiences across the different regulatory frameworks and insights about how to get such innovative technologies to patients sooner and remain compliant.

Learning Objectives:

  • Upon completion, participants will be able to describe the key parts of EU, US and China combination products regulatory frameworks.
  • Upon completion, participants will be able to better formulate suitable regulatory strategies for obtaining marketing approvals of drug-led and device-led combination products in the major markets and remaining compliant post-approval.
  • Upon completion, participants will better understand the challenges of navigating the different global regulatory frameworks for combination products.