AU: TGA releases guidance for paper dossiers using eCTD or NeeS as the source

The Australian Therapeutic Goods Administration (TGA) has released a new guidance document "Paper format: Requirements for industry for providing regulatory information. Using an eCTD format or a NeeS format electronic submission dossier as the source". 

Background information: Currently, the TGA requests paper dossiers and electronic dossiers for the initial registration or for variations to an existing registration for a prescription medicine. The paper submission dossier is the formal (legal basis) submission dossier. Accompanying electronic dossiers must be compliant to NeeS or eCTD. Acceptance of the eCTD is currently limited to New Chemical Entities (NCEs) and/or new combination products. 

The new Guidance document provides instructions for creating a paper submission dossier where the source (original) information is available in the NeeS or eCTD electronic format. Version 1.0 from April 2011 is available for download as PDF file from the TGA website (see link at the bottom of this article).

[Source: TGA website]

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