eCTD Submissions in EU | Latest update

January 19, 2022

| EU, Regulatory Operations: eCTD and Submissions

Version 5.0 of Harmonised Technical Guidance for eCTD Submissions in the EU has been released. This new version will come into effect on February 1st, 2022, substituting previous version 4.0, from April 2016.

Main changes included in this new version are:

More detailed indication on correction of content validation errors
New indications for eCTD lifecycle merging
CESP and EMA Gateway as mandatory submission portals
Tracking Table becomes mandatory for all procedures
New detailed guidance on ASMF and PSUR submissions

At Asphalion, we are experts and can provide you with guidance and assistance for your eSubmissions.

You can request further information by contacting us at: info@asphalion.com

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