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electronic common technical document
eCTD stands for ‘Electronic Common Technical Document’ and is a common technical document in electronic format. This standard has been developed by the ICH M2 Expert Working Group and is maintained by the eCTD Implementation Working Group.The eCTD includes, amongst other components, an XML backbone describing the submission structure and linking to individual files, an ‘envelope’ containing metadata describing the submission, operation attributes describing the lifecycle status of each file, and a leaf title for each file that is another way of identifying the file (in addition to the filename). While the table of contents is consistent with the harmonized CTD, the eCTD also provides a harmonized technical solution to implementing the CTD.
Abbreviation for
Related Term
common technical document
ectd application
modified leaf, ectd
non-ectd electronic submission

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