Creating eCTD Applications

Abstract

The electronic Common Technical Document (eCTD) is defined as an interface for industry to agency transfer of regulatory information, while at the same time taking into consideration the facilitation of the creation, review, lifecycle management and archival of the electronic submission. eCTD is just an ‘envelope’ that will enable industry to communicate and exchange information easily and should be considered only as the final step in the process of generating an electronic submission. The authors firmly believe that optimal eCTD is based on a solid integrated document management system.

Submission management in the generics industry is a process and the document management system should therefore be adapted to support this process of dossier creation and post-application management of hundreds, or even thousands, of dossiers. In order to effectively implement this process, it is highly recommended that a document management system is configured in such away that every individual document is stored in the system only once. The most effective integration of a document management system and publishing system will enable production of a CTD or eCTD from the same initial documents. This will enable companies to support the submission process in cases where only paper submission is needed, only electronic, or both.