Australian regional specification – eCTD Version 3.1

By 14. June 2018Blog

Australia is phasing out eCTD Specification version 3.0 on 30th June 2018. The Therapeutic Goods Administration (TGA) is making changes with eCTD validation criteria, specifically current eCTD Document Matrix (Version 2.0) which forms part of the validation criteria for the eCTD and NeeS and which is one of file downloads for eCTD version 3.1.

From 1st July 2018 the following specifications and validation criteria must be used to ensure successful validation of each sequence:

eCTD format:

  • eCTD Version 3.1 File downloads and checksums
  • Australian eCTD regional specification and validation criteria version 3.1 excel spreadsheets

NeeS format:

  • NeeS Version 2.0 File download, which includes a new NeeS envelope form
  • Relevant eCTD Version 3.1 file download
  • Australian eCTD regional specification and validation criteria version 3.1 excel spreadsheets.

This shift from eCTD Specification version 3.0 to 3.1 should help to avoid possible unnecessary validation criteria errors: to better align with the document validation criteria and to improve TGA evaluation process. Within a new eCTD version 3.1 all sequence types for sections m1-3-1-3, m1-3-2-3, and m1-3-3-3 (PI Approved, CMI Approved, and Mock-up Approved), that had a document requirement rating of ‘E’ (Error) for these sections will now have the less stringent rating of ‘P’ (Possible). This allows for the ‘approved’ PI, CMI, and labels to be provided as a post approval closing sequence.

The main purpose of amendment on file download is to allow updates to each file download as required without the need for a full specification update.

 

Source:

http://www.tga.gov.au/advance-notice-update-ectd-file-download-version-31

https://www.tga.gov.au/electronic-submissions-update-reminder-transition-period-current-australian-regional-specification-ends-30-june-2018