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Australian eCTD specification released

eCTDs are coming to AustraliaNot a big surprise but Australia is moving towards eCTD. The Therapeutic Goods Administration (TGA) recently released two documents:

As noted on TGA's web site, "[i]t is expected that the media for receiving eCTDs initially will be CDs or DVDs and that there will be a transition period where both eCTD and hardcopy CTDs will be accepted prior to eCTDs becoming mandatory".

Thanks to the folks at eCTDBlog for the heads-up!


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