Electronic-only (eCTD) submissions are one step closer
9 October 2012
The TGA currently receives a large amount of data in paper format, which is costly to produce, handle and store. On 28 September 2012, the TGA released a request for tender for software and services to assist the TGA in processing this data electronically.
The TGA will work with members of the pharmaceutical industry to test procedures, develop guidelines and develop a timetable for the introduction of electronic-only prescription medicine applications.
Prescription medicine dossiers (category 1 and 2) currently have to be lodged in paper (hard copy) and electronic forms. A hard copy is currently the authoritative source of data supporting a regulatory application.
The world-wide standard developed by the ICH (International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use) is the electronic Common Technical Document (eCTD).
The TGA does not yet have the ability to fully manipulate eCTD format submission dossiers. This tender process is to provide the TGA with an eCTD review tool so that the TGA will be able to accept dossiers submitted solely as electronic eCTDs.
Further consultation about phasing in electronic-only submissions will be part of the implementation process.
Content last updated: Tuesday, 9 October 2012
Content last reviewed: Tuesday, 9 October 2012
Web page last updated: Thursday, 6 June 2013