BioCentury
ARTICLE | Regulation

Global experiments in rare disease innovation

Overlaps, differences in approaches in Australia, China, India, Korea, the U.K. and the U.S.

February 28, 2026 1:59 AM UTC

As described in the accompanying perspective, emerging models for orphan drug innovation take different approaches to evidence generation, approval pathways, and care delivery.

BioCentury identified six models — in six countries — that are each re-routing the traditional path to patient access to medicines for very rare diseases. ...