21 December 2009

Turkish NeeS Standard

Crawling around LinkedIn, I found another interesting point -- the impacts of the standardized CTD structure are slowly being adopted even outside of the "official" ICH regions of the US, Europe, Japan (and Canada). We've seen this with recent Australian and Swiss guidance, but additional regions and regulators are accepting submission aligned with the CTD.

For example, Turkey appears to be accepting a NeeS-like format aligned with the CTD structure. In it, Turkish versions of the ICH folder structure used in the eCTD and NeeS are recommended, along with several PDF-based TOCs at the Module level.

Translation -- I had to jump through hoops to get this to work. Scroll down to the bottom, but formatting is lost and it is difficult to read. The original "Slide" has the original unstranslated Turkish document.
Original Guidance from Turkish Agency

Is anyone else familiar with other CTD-based standards in use outside of ICH regions?