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…
More episodes of The Life Science Rundown
- TerSera's VP of Quality on the Audit Risk Hiding Inside Your Own Procedures
- Why Kidney Disease Innovation Is a Tale of Two Cities — and What It Would Take to Change That
- Navigating Regulatory Leadership Across Large and Small Life Science with Tammy Sarnelli
- Getting Data Governance for Regulatory Submissions Right Before AI Gets it Wrong with Cary Smithson
- Building Resilient Biotech Teams in Cell and Gene Therapy with Nelly Viseux
- Building Phase-Appropriate Quality from Preclinical to Commercial with Jackie Klecker
Explore listener stats, chart rankings, contacts and more on the The Life Science Rundown podcast page.