Medical Translation Insight

Not a big surprise but Australia is moving towards eCTD. The Therapeutic Goods Administration (TGA) recently released two documents:

• specification for module 1, and a


• draft guidance for industry

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!