eCTD Content Hub

Everything you want to learn about eCTD: timelines, checklists, guides. All in one place.

  • Now: Pilot programs underway across regions
  • Next: Regional adoption and mandatory timelines

Discover Our eCTD 4.0 Resources

eCTD 4.0: What’s Changing and How to Be Ready

[Blog Article]

eCTD 4.0: What’s Happening?

[Podcast]

Global eCTD Regulatory Updates

[White Paper]

Which regulatory updates should you pay attention to?

[Podcast]

Preparing for eCTD 4.0 Pilots

[Blog Article]

eCTD 4.0 Pilot Readiness Checklist

[Download the Checklist]

Ennov InSight Publishing

[Learn More]

Customer Success Story: Laboratoire Aguettant

[Read the Case Study]

Ready for Key Milestones?

Ready to put eCTD 4.0 into practice? You don’t need more guidance documents...

You need proven approaches tested with health authorities

Ennov combines deep regulatory submission expertise, a robust publishing platform, and hands-on pilot execution to support confident eCTD 4.0 adoption.

That experience comes from 11 successful eCTD 4.0 pilot submissions across the EMA, FDA, and PMDA, including direct collaboration with health authority technical teams.

Making eCTD 4.0 Predictable from Day One

eCTD 4.0 introduces new structure, metadata, and configuration choices.
Teams entering early pilots are learning how these changes affect build time, reuse, and long-term scalability.

Getting clarity early helps you move forward with confidence.

READ THE PRODUCT BRIEF
WATCH THE DEMO VIDEO

Expert eCTD 4.0 Services

For Ennov customers or teams who want a head start:

  • Understand what really changes from eCTD 3.2 to 4.0
  • Run pilots without trial-and-error
  • Train publishing teams on real eCTD 4.0 scenarios
  • Make the right configuration decisions from day one
  • Expert guidance when it matters

Best for:
Teams who want to de-risk pilots and prepare before eCTD 4.0 becomes mandatory.

Ennov InSight Publishing

For teams looking for an eCTD 4.0-ready publishing solution:
  • Supports all regions, countries, and submission types
  • Handles large, highly complex submissions
  • Guides publishers through multi-step eCTD 4.0 workflows
  • Reduces ongoing effort when registrations change
  • Integrate with all major DMS environments

Best for:
Organizations evaluating a future-proof publishing platform, not just pilot compliance.

Come join more than 450 Life Sciences companies around the world being powered by Ennov

Frequently asked questions on eCTD

What is eCTD 4.0 and how is it different from eCTD 3.2.2?

eCTD 4.0 is a major evolution of the eCTD standard, introducing structured, message-based submissions with greater use of metadata and controlled vocabularies. Unlike eCTD 3.2.2, it relies less on folder-based navigation and more on XML and data-driven structures, fundamentally changing how submissions are built, validated, and reviewed.

No. While some concepts are familiar, eCTD 4.0 introduces significant changes that impact submission structure, publishing workflows, and day-to-day work for regulatory publishing teams. Organizations that treat eCTD 4.0 as a small upgrade often underestimate the effort and risk involved.

Ennov offers a structured eCTD 4.0 Support Package that brings together:

  • Deep regulatory submission expertise
  • Hands-on training for publishing teams
  • Strategic guidance for pilot selection and execution
  • Fit-for-purpose test environments
  • Ongoing expert support during early submissions

Helping you move from understanding eCTD 4.0 to executing it with confidence.

Yes. Ennov provides an enterprise publishing solution that supports eCTD 4.0, but our eCTD 4.0 support is not limited to software.

Ennov’s publishing capabilities are designed to handle global submission requirements, highly complex and large dossiers, and eCTD 4.0–specific structures and metadata, while integrating seamlessly with existing document management systems. These capabilities are backed by hands-on experience from multiple successful eCTD 4.0 pilot submissions across regulatory regions.

We help de-risk eCTD 4.0 by:

  • Identifying common pitfalls seen in real pilot submissions
  • Recommending suitable products and strategies for first pilots
  • Training teams before they submit
  • Supporting testing in controlled environments
  • Providing direct access to experienced experts during execution

This approach helps avoid rework, failed pilots, and delayed readiness.

Ennov has completed 11 successful eCTD 4.0 pilot submissions across major regions:

  • European Union
  • United States (FDA)
  • Japan (PMDA)

This hands-on experience informs our guidance and ensures recommendations are grounded in real regulatory interactions.

Customers receive direct access to Ennov’s regulatory experts who have worked directly with FDA, EMA, and PMDA on technical pilots and has supported multiple pharma and biotech companies through eCTD 4.0 test and pilot submissions.

Timelines vary depending on your organization, tools, and experience. However, with structured preparation, many teams are able to move from initial assessment to pilot execution in a controlled and predictable manner — avoiding the delays commonly caused by trial-and-error learning.

Now. Even if eCTD 4.0 is not yet mandatory in your region, early preparation allows you to:

  • Build internal expertise
  • Test processes safely
  • Learn through pilots rather than mandates
  • Be ready when timelines accelerate

Early movers consistently experience smoother transitions.

Yes. Ennov’s approach scales to fit both smaller regulatory teams and large global organizations. Support can be focused on a single pilot or expanded to support portfolio-level readiness.

After a successful pilot, Ennov helps you:

  • Capture lessons learned
  • Refine processes and templates
  • Prepare for additional regions or products
  • Move toward operational readiness for future mandates

How can we help you?

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