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Therapeutic Goods

The Therapeutic Goods Administration (TGA) protects the health and wellbeing of the community by regulating and monitoring all therapeutic goods that are distributed in Australia.

If you are conducting research related to a therapeutic good, the TGA offers a dedicated service, SME Assist, to help researchers, small to medium enterprises (SMEs) and start-ups that are developing new medicines and medical devices understand their regulatory and legislative obligations.

To familiarise yourself with the pathways to market authorisation early in your research project visit SME Assist and subscribe to their email list. Information such as guidance articles, interactive decision tools and upcoming events are available for those unfamiliar with regulation.

Therapeutic Goods are regulated by the Therapeutic Goods Administration (TGA) in Australia.

Approved Therapeutic Goods are listed on the Australian Register for Therapeutic Goods for a specific dose, duration and indication.

If a medical practitioner uses an approved good at a different dose, duration or for a different indication to that approved by the TGA, that is 'off-label'.

If a medical practitioner uses an approved good at a different dose, duration or for a different indication to that approved by the TGA, then a CTN Form is required to be submitted.

There are three ways a medical practitioner can use an Unapproved Good in Australia:

  1. Clinical Trial 
  2. Authorised Prescriber
  3. Special Access Scheme

Please refer to the Use of Unapproved Goods website for further details.

Updated 30 January 2019