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Conversations in Drug Development · Yesterday · 37 min

EU Pharma Reform 2026: What Every Developer Needs to Know

In this episode, Katherine Bowen and Shalini Gupta discuss the EU pharmaceutical legislation reform — a comprehensive update to regulations and directives that will affect drug approval, orphan and paediatric rules, exclusivity incentives, EMA structure and timelines, supply obligations, environmental risk assessments, and transparency requirements. Hosts outline the timeline, key practical impacts for sponsors, and recommended next steps: begin preparing now, align regulatory, market‑access and supply strategies, and monitor EMA guidance during the transition period.

0:00 · EU Pharma Reform Overview-37:42
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In this episode, Katherine Bowen and Shalini Gupta discuss the EU pharmaceutical legislation reform — a comprehensive update to regulations and directives that will affect drug approval, orphan and paediatric rules, exclusivity incentives, EMA structure and timelines, supply obligations, environmental risk assessments, and transparency requirements.

Hosts outline the timeline, key practical impacts for sponsors, and recommended next steps: begin preparing now, align regulatory, market‑access and supply strategies, and monitor EMA guidance during the transition period.

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