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1.3 Regulatory process

Page last updated: September 2016

Information Requests

  • Tabulate the TGA regulatory milestones for the proposed medicine (Subsection 1.3.1)
  • List the TGA-approved indications (Subsection 1.3.2)
  • Indicate whether overseas regulatory approval has been obtained and, where TGA approval has not yet been granted, provide Food and Drug Administration (FDA) or European Medicines Agency (EMA) registration reports (Subsection 1.3.3)

1.3.1 TGA approval

All new pharmaceutical products must be registered on the Australian Register of Therapeutic Goods (ARTG) by the TGA before being marketed in Australia.

Complete the information requested in Table 1.3.1 and provide relevant documents with the submission. For submissions undergoing parallel processing, provide regulatory documents requested in Table 1.3.1 to the Pharmaceutical Evaluation Branch (PEB) as they become available.

Table 1.3.1 Progress of TGA application for registration of proposed medicine

Regulatory milestone

Date scheduled/received/expected

Reference to attachment

TGA registration

[insert date]

[insert reference]

If not yet TGA registered:

[insert date]

[insert reference]
  • lodgment of TGA dossier

[insert date]

[insert reference]
  • TGA clinical evaluator’s report

[insert date]

[insert reference]
  • TGA delegate’s overview

[insert date]

[insert reference]
  • ACPM meeting

[insert date]

[insert reference]
  • delegate’s decision

[insert date]

[insert reference]

ACPM = Advisory Committee on Prescription Medicines

1.3.2 TGA-approved indications

State the indication(s) approved by the TGA. These are identified in the ‘Indications’ section of the product information and are listed in the ARTG.

If TGA approval has not been finalised, provide the proposed indication and the draft product information. These should be consistent with any reports or advice received in the regulatory process to date. If the TGA evaluator’s report, delegate’s overview or Advisory Committee on Prescription Medicines advice affects the proposed indication or product information, clearly state this.

1.3.3 Overseas approval status

Provide information on the overseas registration status of the medicine, including registration conditions or boxed warnings that may apply. Provide the registration reports (or most recent interim reports) from the FDA and/or the EMA, if the proposed medicine is not yet TGA registered.