Electronic Common Technical Document

The electronic Common Technical Document (eCTD) is an interface for the pharmaceutical industry to agency transfer of regulatory information. The content is based on the Common Technical Document (CTD) format.

It was developed by the International Conference on Harmonisation (ICH) Multidisciplinary Group 2 Expert Working Group (ICH M2 EWG). As of January 1, 2008, the U.S. Food and Drug Administration announced that the eCTD is the preferred format for electronic submissions. To date, over 98,000 eCTD sequences have been submitted to the FDA. Although the agency has not released an expected target date, the FDA revealed during the 2009 DIA Annual Meeting that it is looking at draft legislation to require eCTD.

The eCTD has five modules

·                     1 Administrative Information and Prescribing Information

·                     2 Common Technical Document Summaries

·                     3 Quality

·                     4 Nonclinical Study Reports

·                     5 Clinical Study Reports

            A full table of contents could be quite large.

            There are two categories of modules:

·                     Regional module: 1 (different for each region; i.e., country)

·                     Common modules: 2-5 (common to all the regions)