The Use of eCTD (Electronic Common Technical Document) in New Drug Submissions for Medicinal Products for Human Use

The Electronic Common Technical Document (eCTD) is an interface developed by the International Conference on Harmonisation (ICH) to enable the exchange of regulatory data and information from pharmaceutical industries to regulatory agencies. The content is based on the Common Technical Document (CTD) format and follows an eCTD specification (found on the following site: http://estri.ich.org/eCTD/eCTD_Specification_v3_2_2.pdf -the latest updates/notices relating to the eCTD specifications are available on the FDA website).

The CTD holds information in the form of modules, sections and documents regarding the quality, safety and efficacy of new pharmaceuticals. This format is used in a marketing authorisation application for human use in European Union, Japan and United States (regions that are party to the ICH – International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use). The CTD defines the content of the common modules (modules 2-5), whereas the contents of the regional module 1 are defined by each of the ICH regions.