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Electronic Common Technical Document (eCTD) submissions have transformed sponsor companies' interactions with global health authorities. Over the past two decades, eCTDs have evolved from a basic electronic substitute for paper to a robust, standardized framework for regulatory communication.
In this blog, Veristat’s Manager of Regulatory Operations, Angie Gray, briefly explains eCTD 4.0, how it differs from version 3.2, and how Veristat can support your organization through this important transition.
👉 What is eCTD 4.0?
The transition to eCTD 4.0 has been a highly anticipated evolution in the regulatory submission landscape. But what exactly does it mean for regulatory professionals and sponsors?
At its core, eCTD 4.0 is a more harmonized, modernized version of the current eCTD format. It brings with it enhanced lifecycle management, improved document reuse capabilities, and greater flexibility across submissions within the same health authority. These changes are designed to simplify processes and reduce redundant effort.
To put it in perspective, think of the industry’s journey from paper to electronic submissions as a leap from analog to digital. Now, with eCTD 4.0, we’re moving from digital to nano—a shift toward precision, efficiency, and smart reuse of regulatory content.
🎥 Listen as Angie explains what eCTD 4.0 means for the industry: Watch the video
👉 Monitoring What Are the Differences Between eCTD 3.2 and 4.0?
As regulatory teams begin to prepare for the transition, a common question arises: How is eCTD 4.0 different from version 3.2?
Here are some of the key distinctions that are reshaping how we approach submissions:
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Document Reuse Across Applications
Documents submitted under the same health authority can now be reused using a unique identifier assigned in the metadata. This allows information—like investigator details—to be referenced in multiple applications without repeated submissions, streamlining the review process.
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Updated Terminology
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“Dossier” is now referred to as an Application
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“Sequence” becomes a Submission Unit
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New Lifecycle Status: Update
A long-requested enhancement, the Update status, enables changes to metadata only, without requiring changes to the content itself—making submissions more agile and accurate.
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Simplified Sequence Numbering
Previously starting initial applications with “0000,” sequence numbers for initial applications will now begin with “1” and can go up to six digits, allowing greater submission flexibility.
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Elimination of Study Tagging Files (STFs)
In a major step toward global harmonization, STFs will no longer be required, aligning the FDA with international practices.
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Module 3 Granularity Changes (3.2.S.1)
What was once submitted as multiple granular files will now be consolidated into a single PDF, simplifying the process and reducing submission errors.
🎥 Listen as Angie breaks down these important differences: Watch the video
👉 How Can Veristat Help?
As the industry moves from theory to action, Veristat stands ready to support your organization through the eCTD 4.0 transition.
With deep expertise in regulatory operations and a team that stays ahead of evolving standards, Veristat partners with clients to ensure compliant, efficient submissions—whether you're using eCTD 3.2 or preparing for 4.0.
This year alone, the Veristat Regulatory Operations team has completed to date:
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473 eCTD submissions, including
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1 Initial New Drug Application (NDA)
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4 Initial Drug Master File (DMF) applications
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These submissions span both US and ex-US health authorities, showcasing our global regulatory capabilities.
🎥 Listen as Angie shares how Veristat can guide your team: Watch the video
We’d value the opportunity to discuss how we can support your submission strategy and regulatory goals. Let’s talk about how Veristat can help you prepare, adapt, and succeed in this new era of electronic submissions.