Electronic Common Technical Document eCTD specification

Electronic Common Technical Document (eCTD) specifications. www.ich.org... 

The Electronic Common Technical Document (eCTD) is the vision for future electronic submissions to the FDA. This specification was developed by the International Conference on Harmonization (ICH) as an open-standards solution for electronic submissions to worldwide regulatory authorities. The FDA has adopted the eCTD as the future replacement for its other e-submission guidance, although for now the older guidance is still in effect. Note that the eCTD still depends largely on submitting text documents as PDF files and submitting data sets as SAS XPORT transport format files. 

Electronic Common Technical Document Specification. ICH M2EWG. Draft Guidance. International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use. ICH eCTD Specification V 2.0. February 12, 2002. 

Analytical scientists have welcomed ICH M4 Q—Common Technical Documentation (CTD) as a globally accepted format to provide information and scientific data in drug application submission. Recently, FDA and EU regulatory agencies have encouraged and allowed applicants for the electronic submission of the common technical documentations using ICH eCTD specification. 

---