20/01/09 - TGA eCTD draft guidance v1.5

The TGA has initiated a project that will culminate with the data dossiers for all prescription medicine applications being received in electronic CTD (eCTD) format. The TGA has published a  Draft Guidance for Industry on Providing Regulatory Submissions for Prescription Medicines in Electronic Format (eCTD) in Australia.

Also part of the TGA project is to develop a specification for the Australian Module 1 (Region Specific information) of the eCTD.

It is expected that the media for receiving eCTDs initially will be CDs or DVDs and that there will be a transition period where both eCTD and hardcopy CTDs will be accepted prior to eCTDs becoming mandatory. (source)

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