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Guidance for industry on electronic prescription medicine submission dossiers

4 January 2011

All category 1 and category 2 prescription medicine submission dossiers must be lodged in paper (hard copy) and electronic format. The TGA will accept electronic copies of the submission dossier in either non-eCTD electronic submission (NeeS) format or eCTD format. The TGA prefers electronic submission dossiers to be lodged in NeeS format as it does not yet have the ability to fully manipulate eCTD format submission dossiers. Lodgement of an eCTD format submission dossier is subject to conditions listed below.

Creating a NeeS format submission dossier

The eCTD folder structure is used for NeeS format submission dossiers. However, navigation through a NeeS format submission dossier is based on electronic tables of contents, bookmarks, and hypertext links.

The following regulatory document provides information on creating a NeeS format submission dossier:

How to access a pdf or Word document

*Large file warning: Attempting to open large files over the Internet within the browser window may cause problems. It is strongly recommended you download this document to your own computer and open from there.

The TGA has closed the consultation period for electronic submission dossier requirements and will be releasing a revised edition of this document shortly. The information in this revised edition will be a mandatory regulatory requirement from 1 July 2011. See the electronic submission dossier consultation page for more information on the consultation process.

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Creating an eCTD format electronic submission dossier

The International Conference on Harmonisation (ICH) Multi-disciplinary Group 2 Expert Working Group (M2 EWG) was established to facilitate electronic communication of regulatory information by evaluating appropriate electronic standards for communication. The EWG evaluates and recommends, as far as is possible, open and non-proprietary Electronic Standards for the Transfer of Regulatory Information (ESTRI) and produces ESTRI guidelines. ESTRI has defined a specification for the electronic common technical document (eCTD).

The eCTD is an internationally agreed set of specifications for an electronic form of the CTD (common technical document). It maintains the structure of the CTD in its organisation of modules, sections, and documents. The eCTD specifications are aimed at enhancing ease of use, life cycle management and information accessibility.

As the TGA does not have the necessary software to fully manipulate eCTD format submission dossiers, the acceptance of an eCTD dossier is subject to the following conditions:

  • eCTD dossiers will only be accepted for new chemical entity, new combination, or new generic submissions
  • eCTD dossiers must comply with ICH specifications.

The following supporting document provides information on creating an eCTD format submission dossier:

How to access a pdf document

This document was produced prior to the release of the current transitional draft CTD Module 1 - Administrative information and prescribing information for Australia and as such does not reflect the required format and structure of this module. Sponsors are advised that it is acceptable to use judgement when creating file and folder names for module 1 of the dossier (see also NeeS guidance document).

Specifications for modules 2 to 5 of the eCTD can be obtained from the International Conference on Harmonisation website.

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Creating a paper submission dossier from an electronic source

This supporting document provides instructions for creating a paper submission dossier where the source (original) information is in the NeeS or eCTD electronic format. This will allow sponsors to use a NeeS or eCTD format submission dossier as the antecedent submission, from which the formal paper submission dossier is then printed.

How to access a pdf or Word document

*Large file warning: Attempting to open large files over the Internet within the browser window may cause problems. It is strongly recommended you download this document to your own computer and open from there.

This document is provided in draft form. To provide feedback, email the Case management team.

eCTD project

The NeeS format for electronic submission dossiers is an interim format. The TGA is engaged in a process which will result, in the longer term, in the phasing out of paper submission dossiers and the lodgement of submission dossiers in eCTD format only. When the TGA is able to fully support eCTD format submission dossiers, it will be communicated to industry and announced on the TGA website.

The TGA eCTD project involves:

  • identification of the TGA requirements for viewing/reviewing software
  • initiation of the procurement of appropriate software
  • identification of internal technical requisites and integration with other business processes
  • identification of changes to the business rules necessary for processing eCTDs
  • production of guidance for industry.

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