Navigating the regulatory landscape in the US and Japan

As regulatory expectations evolve, Sponsors face increasing pressure to ensure clinical data submissions meet the stringent requirements of both the US Food and Drug Administration (FDA) and Japan’s Pharmaceuticals and Medical Devices Agency (PMDA). 

While the two agencies differ in terminology and formatting, their standards share significant overlap, creating opportunities for harmonisation and efficiency.

In this whitepaper, ICON’s data standards experts provide a practical guide to navigating the regulatory landscape in both countries. Learn how to:

• Access and interpret key resources from the FDA and PMDA
• Identify and resolve conflicts between regulatory and industry standards
• Develop a unified submission package that meets both agencies’ expectations
• Leverage automated tools and best practices to ensure compliance
• Avoid common pitfalls that can delay or derail submissions

Whether you're preparing for your first global submission or refining your approach, this guide offers actionable insights to help you reduce risk, accelerate timelines, and improve regulatory outcomes.