The TGA is currently undertaking work to streamline and automate our electronic dossier receipt system. This work is being carried out in two phases:
Phase 1 - automation of the validation and upload of electronic dossiers.
Phase 2 - submission of electronic dossiers via an electronic gateway facility.
Phase 1 is being implemented in combination with our update to version 3.1 of the AU regional specifications and you will begin receiving automated email notification from early June 2018 stating that your eCTD or NeeS sequence has incurred:
- successful validation and upload to our system; or
- successful validation and upload to our system but validation warning/s noted (via separate emails); or
- validation errors resulting in the sequence not being uploaded to our system.
To avoid unnecessary delays please make sure that you have checked that your sequence appropriately validates prior to sending to the TGA.
Please contact eSubmissions (eSubmissions@health.gov.au) if you have any questions regarding the automated emails.