23.09.2010

AU: Revised CTD Module 1 for Australia released by TGA

The Australian Therapeutic Goods Administration (TGA) has released a revised CTD Module 1. This new version incorporates the requirements of the streamlined submission process and was announced in July this year.

The previous version from November 2008 of CTD Module 1 will remain until the updated Australian Regulatory Guidelines for Prescription Medicines are released. For prescription medicine submissions to be lodged from 1 November 2010, please refer to the revised CTD Module 1. The TGA welcomes all feedback to support further improvements and comments should be emailed to the BPR Project team.

It is currently anticipated that the TGA will release a further update in mid 2011.

[Source: TGA website]

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Background Information: drug regulatory submissions to the TGA must currently be done with paper-based dossiers. Up-to-now, no final eCTD specification has been released.

Links:

www.tga.gov.au/docs/html/eugctd.htm

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