ABSTRACT
The value of production of a specification for the creation of an electronic submission based only upon the modules described in the Common Technical Document would be limited. Regulatory authorities will support submissions described by at least two consecutive versions of the Electronic Common Technical Document (eCTD) Specification. The approach to the management of the Specification for the eCTD is to divide the documentation into a series of independent but related appendices. An eCTD Submission is a collection of data objects that follows the eCTD Specification. The main function of the eCTD Submission is data exchange. The international conference on harmonization Web site includes an eCTD template, which is an empty directory structure with a recommended style sheet. A logical document is comprised of one or more CTD table of contents sections that together contain the minimum amount of information to be exchanged.
