The Australian TherapeuticGoods Administration (TGA) has released, on 14 April 2015, the first final specification for the Australian eCTD.

Since late 2014 the TGA wasaccepting eCTD submissions based on draft specification 0.9 in a pilot phase to assess the eCTD readiness of the agency and industry stakeholders and tocollect comments from stakeholders during the ongoing consultation period. Thepilot phase clearly demonstrated the feasibility of the eCTD in Australia andtriggered the finalisation of the eCTD specification. 

A bit surprisingly the first final version of the Australian eCTDwas released as version 3.0 (and not 1.0 which could have beenexpected). Also the corresponding final eCTDvalidation criteria were released as version 3.0.

Timelines

• The TGA will accept eCTD submissions in acc. to the final version 3.0 from 1 June 2015 onwards.


• The current pilot version 0.9 will still be accepted in parallel until 31 December 2015.


• Any eCTD submitted starting 2016 will need to follow the version 3.0 of the specification.

In parallel the TGA iscurrently revising the NeeS format to align the corresponding validation criteriawith the newly released final eCTD validation criteria. Additional guidancematerial for NeeS is being developed and will be released by TGA in the nearfuture. The NeeS format will still be accepted by TGA but a revision of thispolicy is being considered.

Source:TGA (https://www.tga.gov.au/australian-ectd-submissions )