Ennov is proud to be one of only four technology vendors to have successfully submitted an eCTD 4.0 test sequence as part of the European Medicines Agency’s (EMA) ongoing pilot.
Our submission was received, loaded, and reviewed using the EMA’s internal tools. This confirms that Ennov’s Regulatory systems are fully compatible with current eCTD 4.0 requirements. The metadata and PDFs submitted in Module 1 were successfully rendered, signaling readiness for the future of electronic submissions in Europe and beyond.
What This Means for the Market
The move to eCTD 4.0 represents a major shift in how regulatory submissions are prepared and managed. For Marketing Authorization Holders (MAHs), it raises significant questions about readiness, resourcing, and compliance risk.
By participating early and successfully in the EMA’s pilot program, Ennov gives its customers a clear advantage:
- Early confirmation of platform readiness
- Reduced risk and uncertainty around implementation
- No need to switch systems or retrofit compliance workflows
- Confidence that their provider is ahead—not playing catch-up
“While MAHs can’t submit eCTD 4.0 just yet, this gives our customers a clear advantage,” said Diarmuid Waide, senior RIM consultant at Ennov. “When the next pilot phase begins, they’ll be ready—with no last-minute surprises.”
The EMA will expand testing to include MAHs in the coming months. Ennov is continuing active collaboration in the pilot and preparing to support more detailed submission scenarios as they evolve.
A Phased Rollout, But Immediate Value
The EMA’s eCTD 4.0 pilot is being conducted in stages, with tool vendors currently engaged in the first phase. Marketing Authorization Holders will be invited to participate in future testing cycles as the Agency finalizes XML message standards and submission details.
Ennov is actively collaborating with the EMA and other vendors to support the next phase of testing. Our early success positions us and our customers for a seamless transition once formal adoption begins.
Built for Change
Ennov’s Regulatory Suite is part of a fully unified platform designed to support the entire product lifecycle. As regulators modernize their expectations, our customers benefit from a system that adapts without any disruption or data duplication.
We look forward to giving you more updates through every phase of the eCTD 4.0 journey.
Learn more about Ennov’s Regulatory Suite:
