The CTD is organized into five modules. Module 1 is region specific and Modules 2, 3, 4 and 5 are intended to be common for all regions. In July 2003, the CTD became the mandatory format for new drug applications in the EU and Japan, and the strongly recommended format of choice for NDAs (New Drug Application) submitted to the FDA.
EMA are now only accepting submissions which are in the eCTD format. As of January 1, 2008, all electronic submissions must be in eCTD format in the United States, which is facilitated through the FDA Electronic Submissions Gateway (ESG). The Center for Drug Evaluation and Research (CDER — a division of the FDA) receives all NDA submissions and processes on average 20,000 submissions per month across several regulatory programs.
There are clear benefits to using eCTD for new drug submissions — the obvious argument being that less paper makes the whole process a lot faster. (It can take 1 day to obtain a single file from a document room). It also makes it easier to view the dossier as a whole: navigating through the different modules/sections with the use of bookmarks and hyperlinks can be done almost effortlessly in comparison to the paper format. Furthermore, it enables reviewers to instantly identify and review any changes or updates that are required.
As with every process, there are some drawbacks of using eCTD. The software requires trained technical personnel, and it takes time to become familiar with the tool. If a company does not have the right personnel in place, it may be costly to install or the work will need to be outsourced to a vendor which already possesses the infrastructure.
Author: Jill Stevenson - Lead Associate, Regulatory Affairs