Tag Archives: eCTD
Are you ready for the mandatory transition to eCTD for prescription medicines?
In October 2018 the TGA announced the long-awaited timelines for transition to eCTD. A staged implementation has been proposed for prescription medicines to reflect the current industry uptake of the eCTD format. The transition begins with new chemical entity, new … Continue reading
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
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
