• Australia to Launch Consultation on Development of eCTD Guidelines, Timetable

    Australia's Therapeutic Goods Administration (TGA) is preparing to establish procedures, guidelines and a timetable for the implementation of the submission of medicine applications using the electronic Common Technical Document (eCTD), it announced on 9 October. The eCTD is an electronic, module-based regulatory application format developed and maintained by the International Conference on Harmonisation (ICH). The basic premise of the eCTD is to harmonize the layout a...