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ViewAttendees 7

Pharmaceuticals

Conditional Approval and Expedited Pathways: EU and US Regulatory Strategies

Thursday, May 7, 2026
12:00 - 13:00 WEST
Location: Auditorium 3
Description This session will provide a comprehensive overview of conditional and expedited pathways to facilitate the development and approval of drugs and biological products for serious conditions or rare diseases in the United States and the European Union. Expert speakers will discuss the regulatory frameworks around accelerated and conditional pathways (for EU: PRIME, Conditional marketing authorization; for US: Accelerated Approval pathway, Breakthrough Therapy designation, new guidance on Plausible Mechanism Framework to Develop Individualized Therapies that Target Specific Genetic Conditions, etc.), including eligibility criteria, information requirements, and post-approval obligations.

The session will compare strategic considerations for sponsors when planning development programs intended for expedited pathways in the US and EU, highlighting similarities, differences, and practical challenges. A representative perspective from the European Medicines Agency (EMA) will provide additional insight into regulatory expectations and evolving policy trends.

Learning Objectives:

  • Differentiate key conditional and accelerated pathways in the US and EU, including eligibility criteria and requirements.
  • Evaluate strategic development considerations when planning for conditional or accelerated approval in both jurisdictions.
  • Understand post-approval obligations and regulatory expectations associated with conditional approvals.