eCTD Submissions in EU | Latest update

January 19, 2022

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

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