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.
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