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Tag Archives: eCTD

Transition to eCTD is gaining momentum in Australia

At the 2017 ARCS Annual Conference, the TGA announced that applications considered under the priority review pathway will be required to be submitted in eCTD format. In making this important announcement, the TGA acknowledged the clear benefits of eCTD for … Continue reading

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Are you eCTD ready?

eCTD in Australia Following the successful eCTD pilot programme in 2014/2015, the TGA has published the final Australian eCTD specification (version 3.0) which is now mandatory for all dossiers submitted in eCTD format after 1 January 2016. This is an … Continue reading

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