24.03.2011

Australian TGA revises NeeS guidance and seeks comments from stakeholders

The Australian Therapeutic Goods Administration (TGA) has published a revised version of the "Guidance for industry on providing regulatory information in electronic format: Non-eCTD electronic submissions (NeeS) for human medicinal products". The new draft version 2.0 from March 2011 is for consultation and includes the following changes to the initial version as published in December 2010 (see our related News article):

Corrections to Annex II (Example TOC): For clarity, hyperlinks from the TOC to expected document levels have been highlighted, furthermore module numbers were corrected.
The guidance was generally updated to reflect TGA style guide
The terminology has been harmonized with the streamlined submission process
The introduction was updated to explain the process towards fully electronic submission process

Further administrative changes include: consolidation of separate sections on TOCs, bookmarks, and submission media. In addition, linking is provided to external documents and ambiguity in folder naming conventions has been resolved.

The draft guidance is available for consultation. The TGA "is seeking information from industry to understand the impact this proposed regulatory requirement will have, particularly for smaller sponsors". The consultation period is now open and will close on 1 May 2011.

For further information, please visit the TGA's website (see link at the end of this article).

[Source: TGA website]

Links:

www.tga.gov.au/newsroom/consult-pm-nees-110321.htm

<- Back to: News Archiv