14.04.2015

Australian TGA releases final eCTD specification, revises NeeS format

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The Australian Therapeutic Goods Administration (TGA) has released the first final specification for the Australian eCTD.

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

A bit surprisingly the first final version of the Australian eCTD was released as version 3.0 (and not 1.0 which could have been expected). Also the corresponding final eCTD validation 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 is currently revising the NeeS format to align the corresponding validation criteria with the newly released final eCTD validation criteria. Additional guidance material for NeeS is being developed and will be released by TGA in the near future. The NeeS format will still be accepted by TGA but a revision of this policy is beeing considered.

[Source: TGA]

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