Japan has become an increasingly important market for rare disease development, offering a unique combination of regulatory incentives, globally accepted data, and government support programs. Running rare disease studies requires both local expertise and global coordination to help sponsors navigate complexity from study start-up through submission readiness.

In the Topic Guide, you will learn about:

• Up to 50% Subsidies: For eligible orphan drug programs.  
• 9-Month Priority Review: Accelerated regulatory pathways.  
• FDA & EMA Accepted Data: Clinical data recognized for global submissions.  
• No Local Phase I Required: For many global compounds entering Japan.  
• A Partnership Built for Rare Disease: How A2 Healthcare and Medidata combine regulatory experience, patient-focused operational support, and connected clinical technology across 100+ joint studies.