Entering the Dragon: Japan's Market Realities

Japan remains the second (or third) largest pharmaceutical market in the world, yet it is frequently misunderstood by Western biotechs.

The Regulatory Landscape

The PMDA (Pharmaceuticals and Medical Devices Agency) has harmonized significantly with the FDA and EMA, but critical differences remain in:

• Standard of Care (SoC) comparisons
• Ethnic bridging study requirements
• Post-marketing surveillance

Finding the Right Partner

Success in Japan is rarely a solo journey for mid-sized biotechs. Finding a partner who shares your strategic vision is paramount.