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). This includes adhering to FDA submission standards, PMDA submission requirements, and the respective Data Standards Catalogs maintained by each agency.

While the two agencies differ in terminology and formatting, their standards share significant overlap, creating opportunities for harmonisation, efficiency, and success in cross-border regulatory submissions.

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 such as the FDA Data Standards Catalog, PMDA Technical Conformance Guide, and related regulatory documents
• Identify and resolve conflicts between regulatory and industry standards, including CDISC SDTM, ADaM, and Define.xml
• Develop a unified submission package that meets both agencies’ expectations, supporting efficient regulatory dossier preparation
• Leverage automated clinical data validation tools and best practices to ensure compliance with clinical data review standards
• Avoid common pitfalls that can delay or derail submissions

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