White paper:
eCTD v4 Timelines: Objectives, benefits & impact on life science organizations
The electronic Common Technical Document (eCTD) standard has evolved many times over the past 20 years, and its current version, v3.2.2, will soon be supplemented with the introduction of the next major version - eCTD v4. At its core, eCTD v4 is a format change that gives users access to significant new capabilities.
In this white paper, we will explore the evolution of the eCTD format, what is changing in the next major version, and what the objectives and focal points of eCTD v4 are. Furthermore, we will outline the benefits and challenges associated with the transition from eCTD v3.2.2 to v4 - both from a technical and regulatory perspective.
Questions about eCTD v4 answered in this white paper:
1. What is eCTD v4, and how does it differ from eCTD v3?eCTD v4 is the latest version of the electronic Common Technical Document, enhancing submission quality through structured data and enabling document re-use, unlike eCTD v3.
2. What are the primary objectives of eCTD v4?
The main objectives are to streamline submission processing, improve content re-use, and establish clearer communication between sponsors and regulators.
3. What benefits does eCTD v4 offer to life science organizations?
eCTD v4 enhances review efficiency, reduces resource use, and improves collaboration with third parties in the submission process.
4. How will the transition to eCTD v4 impact regulatory submissions?
The transition will require updates to submission processes and tools, but the benefits in efficiency and quality will be significant.
5. What role does EXTEDO play in the transition to eCTD v4?
EXTEDO supports organizations in transitioning to eCTD v4, leveraging our experience with global health authorities to ensure alignment with industry needs.
Download our white paper now to discover detailed information about eCTD v4 and how it will affect your existing life science business processes.
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