AU: TGA releases new transitional version of CTD Module 1 to be used from March 2011 onwards

The Australian Therapeutic Goods Administration (TGA) has posted a new transitional version of the Common Technical Document (CTD) Module 1 for Australia. This new version from January 2011 is applicable for all CTD submissions received at the TGA from March 2011 on and supersedes the last draft version which was released in September 2010 (see our related News article) and that is currently in use.

According to the document change record, the new version from January 2011 contains only minor corrections and clarifications in all sections. Like the September 2010 version, the newly released CTD Module 1 from January 2011 is being released as a transitional document. The TGA therefore "welcomes all feedback to support further improvements".

The new transitional CTD Module 1 can be downloaded from the the TGA's website (see link at the bottom of this article).

[Source: TGA website]

Related News:

 AU: TGA releases guidance for paper dossiers using eCTD or NeeS as the source - 05.05.2011 15:23

 AU: Revised CTD Module 1 for Australia released by TGA - 23.09.2010 18:19

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