The Swiss Health Authority Swissmedic will accept applications in eCTD format starting in January 2010. They have an announcement for all this on their website, but it doesn't do you much good unless you read German, which sadly, I cannot.
Australia has put out some updated guidance and draft guidance on eCTD. There is now a version 2.1 of the AU Module 1 Specification, and a draft version 1.5 of their guidance on submissions in eCTD format. Both can be found on the TGA's website, the link is below. Happy reading!
Welcome back to work everyone!!! I hope that you all enjoy a happy and prosperous 2009, we certainly all deserve it I think after that mess of a last year. Anyway, back to work....
