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Submissions received and high level summary: Transition to eCTD only for prescription medicines

3 January 2019

Submissions received: Transition to eCTD only for prescription medicines consultation

The TGA would like to thank respondents who provided submissions in response to the October 2018 public consultation paper, Transition to eCTD only for prescription medicines.

A total of 22 submissions were received. Of those submissions, 19 were from industry and regulatory consultants, 2 from industry representative groups, and 1 from a software vendor.

All submissions that gave permission to be published on the TGA website are now available below in PDF format. An additional 8 of the received submissions have claims to confidentiality or privacy that prevent the publication of submission, and/or identity.

High level summary

The proposed change to the allowable formats is one part of a broader electronic dossier reforms agenda to provide an updated electronic submissions platform that is appropriate for Australian stakeholders and observes and adopts some of the best-practice initiatives that are operating in the international environment. Providing a single, standardised dossier format forms part of this agenda.

The electronic Common Technical Document (eCTD) is the internationally recognised standard prescription medicine dossier format and as such the TGA has proposed a phased introduction for the mandatory use of the eCTD format for all prescription medicine dossiers. The consultation sort to further understand the possible impacts on stakeholders and use the feedback received to assist with devising appropriate mechanisms to implement the proposed changes.

The mandating of the eCTD format for prescription medicines only was supported by most stakeholders. The manner in which the introduction should be actioned and the need for additional support programs was subject to mixed views. Key areas of concern and interest for stakeholders were:

  • Timelines for the transition to eCTD only for prescription medicines
  • Cost and resource considerations for this transition
  • Implications for non-prescription medicines
  • Introduction of a portal to support the uploading of dossiers/data
  • Provision of additional guidance and support
  • Mechanism of further stakeholder engagement
  • Plans for the broader electronic dossier reforms agenda

Next steps

Feedback from the responses will be considered and incorporated into the transition plan where appropriate. An Outcome Summary and further details will be published in early 2019.

A revised transition plan, including a revision to the Stage 1 implementation date affecting New Chemical Entities (NCE), New Biological Entities (NBE), Biosimilar Medicines and New Combination Medicines will be included in the Outcome Summary.


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