The AU-TGA (The Therapeutic Goods Administration (TGA) is part of the Australian Government Department of Health) is looking towards moving to submit applications in electronic format to enter registered medicines into the Australian Register of Therapeutic Goods (ARTG). An Australia TGA eCTD created a standard set of procedures, guidelines and agenda to implement the submission of medicine applications using/through the electronic Common Technical Document (eCTD).

Australia TGA eCTD software which is required for validation and review of electronic applications, for the approval of registered medicines (new chemical entity, major variations to a prescription medicine and generic medicine) to the Australian Register of Therapeutic Goods (ARTG).

The Australia TGA eCTD Module 1 Specifications version 3.1 are valid from 1 Jan 2018 onwards.

The Australia TGA eCTD Module 1 Specifications draft version 0.90 and validation criteria, draft version 0.90 are valid until 31 December 2015, after that version 3.1 will be mandatory for eCTD submission.

KnowledgeNet – eCTD Software can be used for submissions in both electronic Common Technical Document (eCTD) and non eCTD (NeeS) formats. The software is ready for submission in version 3.1.

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