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Electronic submission dossier requirements

Consultation

21 March 2011

This consultation closed on 1 May 2011.

The TGA invited comment on proposed mandatory requirements for electronic submission dossiers lodged under the streamlined submission process.

Background

From the beginning of the transition period for the streamlined submission process on 1 November 2010, all category 1 and category 2 prescription medicine submission dossiers must be lodged in paper (hard copy) and electronic forms.

The TGA will accept electronic copies 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. Should sponsors wish to lodge a submission in eCTD format, a number of conditions apply (as noted at footnote 1 in the proposed NeeS regulatory document below).

The requirements for NeeS format submission dossiers were first released on 4 January 2011 in the draft Guidance for industry on providing regulatory information in electronic format: Non-eCTD electronic submissions (NeeS) for human medicinal products.

In response to feedback from sponsors, the TGA has made a number of amendments and clarifications to this document. The proposed regulatory requirements are now established in:

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Rationale for NeeS requirements

The TGA is engaged in a process which will result, in the longer term, in the phasing out of paper submission dossiers. This transition to a fully electronic environment is complex and requires several intervening phases.

The first phase was the TGA requirement under the streamlined submission process that submission dossiers be lodged in both paper and electronic format. The TGA is pleased that sponsors have generally adhered to this requirement. The electronic submission dossier, compiled according to regulatory requirements, is a critical part of the streamlined submission process as it allows the TGA to meet the tight timeframe allocated to milestone 2 where the TGA must consider a submission as either effective and accepted for evaluation, or not effective and not accepted for evaluation.

The second phase is to ensure clarity and to mandate the regulatory requirements for an electronic submission dossier. This current consultation process is part of the second phase.

This second phase will inform the shape and scope of the third and subsequent phases towards the goal of fully electronic eCTD submission.

Consultation

In recognition of the potential adjustments for many sponsors, the TGA is seeking information from industry to understand the impact this proposed regulatory requirement will have, particularly for smaller sponsors.

The TGA welcomes comment on any aspect of the proposed regulatory requirements, and sponsors may consider the following issues:

  • clarity of proposed regulatory requirements for sponsors
  • details of potential barriers to compliance with proposed regulatory requirements.

The consultation period closed on 1 May 2011.

It is the intent of the TGA to mandate the regulatory requirements from 1 July 2011.

Notes on submissions

A list of parties making submissions and all submissions received will be published on the TGA's website. For submissions made by individuals, all personal or identifying details, other than name, will be removed from the submission prior to publication on the TGA website. If individuals do not wish to have their name included, this must be specified.

Contact

Case management team