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.
Read more about Electronic Common Technical Document: Pharmaceutical Point of View
Famous quotes containing the words electronic, common, technical and/or document:
“The war was won on both sides: by the Vietnamese on the ground, by the Americans in the electronic mental space. And if the one side won an ideological and political victory, the other made Apocalypse Now and that has gone right around the world.”
—Jean Baudrillard (b. 1929)
“It is a common accident for men camping in the woods to be killed by a falling tree.”
—Henry David Thoreau (1817–1862)
“Where there is the necessary technical skill to move mountains, there is no need for the faith that moves mountains.”
—Eric Hoffer (1902–1983)
“... research is never completed ... Around the corner lurks another possibility of interview, another book to read, a courthouse to explore, a document to verify.”
—Catherine Drinker Bowen (1897–1973)