Hank's Crystal Ball: Australian eCTD Release

It's so rare in life that I make an accurate prediction, that even when fairly expected things like Australia releasing their eCTD specification happen, it make me soooo happy and proud of myself.

I predicted back in September that Australia would release their eCTD specification in 2009, and I was right! Like clockwork, TGA has posted:

• Aussie eCTD M1 Specification
• Aussie eCTD Draft Guidance to Industry

The initial look at this appears to be somewhat similar to the European eCTD. We will continue to monitor this guidance and provide an update in a later post.