Electronic Common Technical Document (eCTD)

The M2 EWG is developing a specification for an electronic common technical document (eCTD) which is based on the ICH M4 CTD Step 4 documents.  The Steering Committee signed the Step 2 eCTD Specification in February 2002.  See the following documents and files for the Step 2 specification.

• Step 2 eCTD Specification (PDF) (MS Word)
• ICH eCTD DTD version 1.0
• ICH eCTD DTD MD5 Checksum
• February 2002 M2 EWG Meeting Summary
• Self-extracting ZIP file for all of the above documents

A default style sheet is provided here.  This style sheet allows two users to view the eCTD submission, independent of the review environment of each user.  The minimum requirement for using this ICH eCTD Display is Microsoft Internet Explorer 5.0. 

• ICH eCTD Display Version 1.5 (This is an XML file, choose "save target as" not "open")
• Instructions for the ICH eCTD Display (PDF) (MS Word)
• ICH eCTD Display with a sample CTD submission (zipped format)

Regional Regulatory Authorities have additional information on how to prepare and submit eCTD submissions.  See these sites for regional information:

European Union: http://esubmission.eudra.org/ectd

Ministry of Health, Labor and Welfare (Japan): http://www.nihs.go.jp

Food and Drug Administration (United States): http://www.fda.gov/cder/regulatory/ersr/FDARegional/eCTD.htm.

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Page Updated: 21 July, 2003