Updated Australian Submission Guidances

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TGA have today released updated guidances to align Australian CTD Module 1, regional eCTD v3.0, NeeS v1.0 and general dossier requirements, also effective today.

The alignment of these guidances, along with the declaration that paper copies are no longer required, will greatly ease & simplify the submission of electronic dossiers in Australia.

Pharma To Market is up-to-date with all relevant requirements and is able to publish your submissions in the latest formats and offer guidance & information on transition strategies. Contact us to find out how our services can assist your next submission.