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Regulatory Focus™ > News Articles > Australia to Launch Consultation on Development of eCTD Guidelines, Timetable

Australia to Launch Consultation on Development of eCTD Guidelines, Timetable

Posted 09 October 2012 | By Alexander Gaffney, RAC 

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 and format of pharmaceutical submission documents to the extent possible to allow for easier and faster filing and reviews of applications.

The eCTD format has already been adopted by some of the world's largest regulatory bodies, including the US Food and Drug Administration (FDA), the European Medicines Agency (EMA) and Japan's Ministry of Health, Labor and Welfare (MHLW).

TGA said it intends to work closely with the pharmaceutical industry to establish an eCTD framework in Australia, as well as a timetable for the transition.

Current applications to TGA are submitted in both paper and electronic format, which TGA acknowledged is costly and difficult to process. Though the electronic forms allow for somewhat easier processing, the hard copy submitted to TGA is deemed to be the, "Authoritative source of data supporting a regulatory application."


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