ABSTRACT

Electronic submissions have been part of the regulatory landscape for over 15 years since the first formats were developed in the early 1990s. The electronic Common Technical Document (eCTD) is an International Conference on Harmonisation (ICH) created and maintained format for electronic submissions that aims to support the regional and international submission requirements of the Common Technical Document (CTD) in the three ICH regions [European Union (EU), United States (U.S.A.), and Japan] and beyond.