eCTD
• Technical Perspective
• Structured set of common folders structure containing PDFs and SAS files (Statistical Analysis Software) on a CD/DVD (Can also be submitted through Agency web portals)
• The eCTD backbone is an XML file (Extensible Markup Language) representing the structure of the submission, it includes links to files and other metadata such as check sum information. The schema for the XML is very rigid.
• PDF hyperlinks
eCTD Modules
• When making an electronic submission, each document should be provided as a separate file.pp
• The documents, whether for a marketing application, an investigational application, or a related submission, should be organized based on the five modules in the CTD:
•Module 1 includes administrative information and prescribing information,
• Module 2 incl des CTD s mmar doc ments
• Module 2 includes CTD summary documents,
• Module 3 includes information on quality,
• Module 4 includes the nonclinical study reports, and
• Module 5 includes the clinical study reports.