Switching from eCTD v3.2.2 to eCTD v4.0 - impact and consequences 

The current version, v3.2.2, is utilized by most global health authorities, including US FDA, EMA, Canada, and Japan, amongst others. Version 4.0 of the electronic Common Technical Document (eCTD) is the upcoming next major version (NMV) of the electronic submission format. The core objective of the new eCTD standard is to better facilitate the processing and review of electronic submissions between sponsors and regulators, as well as promote better re-use of content.

In addition, the standard brings various advantages for the industry and authorities:

Streamline the review of electronic regulatory dossiers – the bi-direc­tional communication between sponsors and agencies will significantly streamline the overall review process of electronic dossier applications.

Re-usable content – eCTD v4.0 will allow for document re-use, where each document will be assigned a unique ID that can be referenced as long as it’s in an Agency’s system. This will eliminate the need for file paths and will reduce the time and resources spent on creating documents from scratch.

Better document management – the various new features, such as Con­text of Use and Document Groups, will significantly improve the document management lifecycle by presenting a reviewable structure and bringing context into the existing content.

Metadata corrections – with eCTD v4.0, metadata will be used for every­thing from application type to review status to type of document. Addi­tionally, the upcoming version will allow for metadata corrections in follow-up submissions without the need to resubmit documents in updated sections.

Better life-cycle capabilities – another major achievement of eCTD v4.0 will be the ability to replace one document with many and vice versa, thus enabling better lifecycle capabilities on submissions.

Increased Harmonization – the new version of eCTD strives for in­creased global harmonization between agencies, vendors, and sponsors.

The switch to the new version of eCTD 4.0 brings numerous benefits for both industry and government. Both benefit from smoother and, thus, faster processing and verification of electronic applications.  Is your organization ready for eCTD 4.0? 


If you would like to learn more about eCTD 4.0 and its implementation, have a look at our latest Blog Post When can companies expect to use eCTD 4.0? | EXTEDO.


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