Uploading Electronic Common Technical Documents (eCTD)

Table of Contents

Everlaw supports native uploads of electronic common technical documents (eCTD). This is the standard format used for the transfer of regulatory information between pharmaceutical companies and government agencies. 

Uploading eCTD data

To upload these files each eCTD "bundle" should be submitted as native data  as a zip or in its own directory  which should contain at least an "index.xml" file, the corresponding "index-md5.txt" file, and a "util" directory. Multiple eCTD directories can be combined and uploaded together inside a container or nested under a top-level directory, but they should not be uploaded with other loose files.

eCTD processing 

When processing eCTDs Everlaw will

  • extract the documents contained within the eCTD
  • extract titles for documents referenced by the XML files as metadata
  • generate an HTML file to display the contents of the XML files (e.g. index.xml)
  • ignore files in the util directory that do not contain content (e.g. stylesheets)
Have more questions? Submit a request


Article is closed for comments.