The guidance on marketing applications for drugs and

biologics, known as the Common Technical Document (CTD), was

finalized by the International Conference on Harmonization

(ICH) in 2003. Today the CTD format is mandatory for

paper-based marketing applications in Europe, Japan, Canada,

and other regions, and is highly recommended by FDA.

The eCTD format has become mandatory in key regions for

electronic submissions. Since January 2010, the European

Medicines Agency has required all applications in the

centralized procedure use the eCTD format. Since January

2008 FDA CDER has required all electronic submissions be in

the eCTD format. FDA CBER requires the eCTD format for

priority review and rolling submissions.