eCTD News

 January 4th 2011:

TGA releases draft Guidance for industry on providing regulatory information in electronic format: Non-eCTD electronic submissions (NeeS) for human medicinal products.

The draft TGA NeeS guidance follows the European TIGES standard including requirements for bookmarks and hyperlinks and text searchable documents. Folder naming conventions are also provided for the Australian Module 1, whilst Modules 2-5 follow the ICH eCTD file naming conventions. From 1 November 2010, it is a requirement that all Category 1 and Category 2 prescription medicine submission dossiers received at the TGA are provided in both hard copy and electronic forms. The TGA is also working to develop requirements for eCTD dossiers.

Download a copy of the draft guidance from the TGA's website here.