TGA Guidance: General Dossier Requirements

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:

1. To register a medicine (prescription, OTC or complementary) on the ARTG

2. To include a biological on the ARTG that requires evaluation of information

3. 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.

4. To list an assessed listed medicine (where information is required for evaluation)

5. For medical device (including IVD) conformity assessment certification

6. For evaluation of new ingredients for use in listed medicines

7. 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 D: How and where to send your dossier

• Part E: Hard copy (paper) dossiers

Download the printable version of this guidance by clicking this LINK.