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The Australian Therapeutic Goods Administration (TGA) has released a guidance on electronic prescription medicine submission dossiers entitled "Guidance for industry on providing regulatory information in electronic format: Non-eCTD electronic submissions (NeeS) for human medicinal products". The NeeS guidance can be downloaded from the TGA website in PDF format. The guidance document, which is considered as a draft by the TGA, details the format and requirements on NeeS submissions for human medicinal products.
Since November 2010, all category 1 and category 2 prescription medicine submission dossiers received at the TGA must be provided in both hard copy and electronic format. Electronic formats accepted are NeeS and eCTD. The announcement goes inline with the TGA´s "Streamlined submission process" project. According to that, November 1st, 2010 was the start of a 12-month transitional phase.
A draft guidance regarding the Australian eCTD requirements as well as a draft Australian Module 1 specification have been published earlier by the TGA. As the eCTD is still under further development, further guidance regarding eCTD is expected in the near future. Transitional mandatory requirements for an effective submission have been released in October 2010.
The newly released NeeS guidance follows in principle the EU TIGes NeeS guidance with regard to format, structure and file types. In addition, file names for module 1 are provided in the guidance.
The electronic submission dossier must be provided in 6 (six) copies together with a paper dossier following the mandatory CTD format.
[Source: TGA website]
- Related News:
 Australian TGA revises NeeS guidance and seeks comments from stakeholders - 24.03.2011 12:36
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