Recently on 27th October, 2023 Australia's Therapeutic Goods Administration (TGA) released an updated guidance on the "General Dossier Requirements". The updates were related to the Amendments to Part C to update the reference for dossier requirements for biologicals.
Applicants should use this guidance to meet the TGA requirements for the dossiers. The following types of applications are in scope:
To register a medicine (prescription, OTC or complementary) on the ARTG
To include a biological on the ARTG that requires evaluation of information
To include a medical device (including IVD) on the ARTG if you have been advised that it will be audited and requested to provide information for the audit.
To list an assessed listed medicine (where information is required for evaluation)
For medical device (including IVD) conformity assessment certification
For evaluation of new ingredients for use in listed medicines
To vary the ARTG record which requires supporting information
The General Dossier Requirements are classified into parts A to E.
Part A: Requirements for all dossiers
Part B: Electronic dossiers
Part C: Formatting your dossier
Part E: Hard copy (paper) dossiers
Download the printable version of this guidance by clicking this LINK.
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