Syncing Global Regulatory Filings Across FDA, EMA, and PMDA with AJ Acker

About this episode

AJ Acker discusses the complexities of navigating global regulatory filings across the FDA, EMA, and PMDA, emphasizing the importance of early preparation and regional engagement.

What does it actually take to navigate global regulatory filings across the FDA, EMA, and PMDA, and why do so many programs stumble despite technically harmonized dossiers? AJ Acker draws on about 30 years of rare disease regulatory experience to break down the real differences between regions and the strategies that drive successful multi-regional approvals. AJ discusses why ICH compliance doesn't equal regulatory alignment, how Japan's evolving regulatory landscape creates both opportunity and complexity, and why the preparation that starts early in development (not at submission) is what determines whether a program achieves tight global approval timelines. A few of AJ's key takeaways: FDA, EMA, and PMDA share the same goal but ask fundamentally different questions — sponsors need to understand each lens, not just the shared science ICH harmonization provides a common foundation, but technical alignment is not regulatory alignment — region-specific engagement is essential Start planning for all three regions early, especially Japan — PMDA will ask why they weren't included in early development Expect different regulators to want different endpoints from the same data — early…

People in this episode

Guest: AJ Acker

Topics covered

• global regulatory filings
• FDA
• EMA
• PMDA
• rare disease
• regulatory strategies
• multi-regional approvals

Keywords

• regulatory alignment
• ICH compliance
• development planning
• endpoint differences
• simultaneous filings
• regulatory landscape
• strategic advisors

Mentioned in this episode

Organizations: FDA, EMA, PMDA, ICH

Places: Japan

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