Norwegian Agency Supporting eCTD?

Google Translate Even Does Norwegian! Who needs regulatory translation services?

Seems like the Norwegian authorities are simply reiterating the EMEA drive to eSubmissions.

Recent Japanese Guidance Update for eCTD

Guidance updates are always a tricky thing. Japanese guidance updates for a Gaijin can be even trickier. For starters, there's the language gap. Secondly, there's the fact that the Guidance tends not to be written in one document, but rather spread across several updates. Here's the primary notification and a sample.

Notification (original)
Translation - Prepare to be creative in your interpretation, but hey -- Google Translate's English is better than your Japanese! :)
Sample M1 XML

As I understand it, the recent Japanese guidance revision consists mainly of the following:

• Clarification of content block titles in M1-01 and M1-09
• Addition of two levels of subsections under section M1-13
• Additional available submission types
• Clarification that all content blocks should be compiled out, even if documents are not included under them

From what we understand, the new specification should be being used ASAP, so consult your local partners\eCTD software vendors for support.