Welcome back to the Ennovation Podcast, where we bring you the latest trends, insights, and expertise in life sciences and regulatory affairs. This time, I’m joined by Diarmuid Waide, Regulatory Product Specialist here at Ennov, for a behind-the-scenes look at the EMA’s eCTD 4.0 pilot and what it revealed about the gap between theory and real-world readiness.
From Specs to Submissions
What the EMA pilot taught us about eCTD 4.0 readiness
Diarmuid worked closely with customers and developers throughout the EMA pilot, supporting both submission execution and system adaptation. In this episode, he shares what it really felt like to move from specs and training into live submissions—from metadata confusion to validation errors that required fast action and cross-team problem-solving.
One clear takeaway: documentation helps, but nothing beats experience. The customers who jumped in, tested early, and submitted iteratively were better positioned to adapt. And thanks to their feedback, the Ennov platform evolved rapidly, making eCTD 4.0 feel more intuitive, even as the standard itself introduces new layers of complexity.
If your team is preparing for submissions to EMA or other health authorities adopting 4.0, this episode is full of practical insight.
Pilot Success is Powered by Partnership
Ennov has supported eleven successful eCTD 4.0 pilot submissions—six to the EMA, three to the FDA, and two to Japan’s PMDA—demonstrating our deep hands-on experience across all major regulatory-led pilots to date. Our team worked side by side with customers to configure systems, troubleshoot submissions, and ensure success.
This momentum matters. The EMA began accepting eCTD 4.0 submissions in December 2025, and more pilots are launching in 2026 across Australia, Switzerland, and Canada. Ennov customers are ready to move forward with confidence.
Our Top Resources
Get everything in one place: Visit the eCTD 4.0 resource hub
Track key implementation deadlines: Explore the updated eCTD 4.0 timeline
Know what’s changing and why it matters: Read the readiness guide
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