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 common knowledge to every schoolboy and even every Bachelor of Arts,
That all sin is divided into two parts.
One kind of sin is called a sin of commission, and that is very
important,”
—Ogden Nash (1902–1971)
“The best work of artists in any age is the work of innocence liberated by technical knowledge. The laboratory experiments that led to the theory of pure color equipped the impressionists to paint nature as if it had only just been created.”
—Nancy Hale (b. 1908)
“What is a diary as a rule? A document useful to the person who keeps it, dull to the contempory who reads it, invaluable to the student, centuries afterwards, who treasures it!”
—Ellen Terry (1848–1928)