eCTD submission update

The TGA announced on 26 February 2014 the signing of an agreement to purchase software that will be used to receive, review and process electronic applications for registered medicines. The TGA has since been working with the supplier and industry stakeholders to prepare for a pilot submission programme.

This has involved the development of a revised Australian Common Technical Document Module 1 which is largely aligned with the European version and is a key input into development of technical documents necessary for the creation of eCTD format submissions. Preliminary versions of these documents will be available on the TGA website shortly.

The TGA will need pilot submissions from industry to test the new system before its official launch in early 2015. A workshop is planned for 3 July 2014 and if you are interested in participating in the pilot programme or intend submitting an electronic submission in early 2015, you may wish to attend. Full details on the workshop will be published on the new esubmission web pages that are about to be published. Please note that attendance at the workshop is not a prerequisite for participation in the pilot.

Interested stakeholders are encouraged to review the information that will be published on a new dedicated web page. This page will be updated as the project progresses and comment on any aspect of the use of eCTD submissions can be provided to TGA using emails to esubmissions@tga.gov.au.