The Therapeutic Goods Administration (TGA) intends to make a small amendment to the eCTD validation criteria. Specifically the amendment is to the current eCTD Document Matrix (Version 2.0) which is one of the file downloads for eCTD version 3.1 and which forms part of the validation criteria for both the eCTD and NeeS submissions.
This amendment will provide better alignment with the document validation criteria and the current TGA evaluation process, and thereby avoid possible unnecessary validation errors.
The amendment is to the document requirement for sections m1-3-1-3, m1-3-2-3, and m1-3-3-3 (PI Approved, CMI Approved, and Mockup Approved). All sequence types that had a document requirement rating of 'E' (Error) for these sections will now have the less stringent rating of 'P' (Possible). This change allows for the 'approved' PI, CMI, and labels to be provided as a post approval closing sequence rather than as part of the next submission.
The current eCTD Document Matrix (Version 2.0) appears on the Electronic Submissions page of the TGA website as one of the XML format 'file downloads' for eCTD version 3.1. The updated eCTD Document Matrix (Version 2.1) will come into effect on 22 June 2018, when it replaces the current eCTD Document Matrix (Version 2.0). A screen shot of the relevant portion of the update is shown below.
The purpose of having the file downloads as separate documents to the remainder of the validation criteria is to allow updates to each file download as required without the need for a full specification update.
Preferably, software vendors will access the downloads directly from the TGA website rather than incorporating them directly into their own software. That way the latest version of each file download will always be utilised in the vendor's validator. This allows greater flexibility for both the TGA and industry to manage changes as responsively as possible.
Please contact the electronic submissions team at EDR@health.gov.au if further clarification is required.