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Australian clinical trial handbook

Guidance on conducting clinical trials in Australia using 'unapproved' therapeutic goods

12 October 2018

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Advertising 'unapproved' therapeutic goods

It is an offence to advertise any therapeutic good that has not been included in the ARTG under the Therapeutic Goods Act 1989 (section 42DL(1)). While the trial sponsor would be able to promote their trial in the public domain, they could not specifically mention the name of the therapeutic good being used in the trial.

Section 42DL(1) also notes a person may not publish or broadcast an advertisement about therapeutic goods that contains a prohibited or restricted representation, or that contains a statement referring to goods, or substances or preparations containing goods, included in Schedule 3, 4 or 8 to the current Poisons Standard.

An 'advertisement', in relation to therapeutic goods, includes any statement, pictorial representation or design, however made, that is intended, whether directly or indirectly, to promote the use or supply of the goods.

A person must not make a claim that they can arrange the supply of goods not in the ARTG (Section 22(6), 32BJ(4)(a) and 41MM of the Therapeutic Goods Act 1989).

Any advertisement for a clinical trial should be approved by the HREC reviewing the trial as specified under section 5.2.23 of the National Statement and section 4.4.1 of the Guideline for Good Clinical Practice.

See Regulation of therapeutic goods advertising in Australia for an outline of the requirements for advertising therapeutic goods.

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