TGA consultation: proposed improvements to the Therapeutic Goods Advertising Code

The Therapeutic Goods Administration (TGA) has published a consultation paper seeking stakeholder feedback on options and proposed changes to improve the Therapeutic Goods (Therapeutic Goods Advertising Code) Instrument 2021 (the Code).[1]

This post highlights key proposals that are the subject of the consultation paper.

Part 1 – proposed improvements

Advertising requirements for software-based medical devices

Following a 2024 TGA review of the regulation of AI and software as medical devices (SaMD), stakeholders advocated for the appropriateness of advertising rules that are tailored to software-based medical devices, including those incorporating artificial intelligence (AI). The consultation paper identifies several problems including:

• consumers and health professionals not being able to easily determine whether an SaMD in an app store is included on the Australian Register of Therapeutic Goods (ARTG) and
• there being no specific requirement to disclose the use of AI in SaMD.

The consultation paper presents four options to better reflect the unique challenges associated with the advertising and supply of SaMD products:

1. improving ARTG transparency by requiring ARTG numbers to be displayed in SaMD advertisements
2. introducing software specific mandatory statements
3. requiring health warnings to be included in advertisements that facilitate the direct purchase or supply of a SaMD
4. introducing disclosure requirements for SaMD that incorporates AI.

Whether to allow paid testimonials for therapeutic sunscreens

Section 24 of the Code prohibits the use of testimonials in advertising from persons involved in the production, marketing or supply of therapeutic goods, including paid social media influencers. Some stakeholders have advocated for an exception for therapeutic sunscreens, arguing that influencer testimonials about physical attributes (such as texture, scent and residue) would promote sun-protection behaviours, particularly among adolescents. The TGA’s current preference is to retain the existing prohibition, including because of perceived conflicts of interest associated with the use of paid testimonials.

Part 2 – proposed clarifications and amendments

The TGA proposes several targeted amendments to improve the clarity and consistency of the Code, including:

(Definition of ‘prominently displayed or communicated’): Amending the definition in section 4 to expressly reinstate the requirement that visual statements must ‘stand out’, to resolve ambiguity that resulted when this requirement was removed from earlier versions of the Code.

(Exemption for permitted vaccine advertisements): Restricted representation permissions under section 42DK of the Therapeutic Goods Act 1989 allow certain vaccine advertising that would otherwise be prohibited. The TGA proposes an exception so that advertisements made under a section 42DK permission are not subject to the requirements in section 19(1) of the Code (that are said to be incompatible with vaccine advertising).

(Vaccine-preventable diseases as restricted representations): Amending section 28 to clarify that all vaccine-preventable diseases (regardless of severity) are ‘serious forms’ of disease for the purposes of prohibitions on restricted representations.

(Additions to the permitted samples list): Adding disposable insulin pen needles (with conditions restricting sample supply to existing trained insulin-pen users) and unmedicated topical nappy rash products to the list of goods that may be given as free samples in advertising. Notably, the TGA does not support adding topical pain relief products, topical scar treatments, or the broader category of skin barrier emollient/moisturising preparations to the list.

Part 3 – administrative amendments

The TGA proposes several minor administrative changes including clarification that the general advertising requirements in Part 4 of the Code continue to apply to advertisements covered by Division 2 (such as pharmacist-only medicines and short-form advertisements).

Part 4 – issues that will be addressed in advertising guidance

The TGA proposes to update guidance (rather than amending the Code) to clarify:

1. what constitutes ‘generic information’ under the Therapeutic Goods Act and Regulations and
2. citation requirements under section 11(3) of the Code for advertisements referring to scientific or clinical research, including illustrative examples of express versus implied references. The examples set out in Attachment 1 of the consultation paper are not exhaustive and are intended to help advertisers understand when the citation requirements in subsection 11(3) of the Code are triggered.

Next steps

Responses may be submitted on the consultation page until 3 September 2026.

Sponsors, advertisers, and other stakeholders in the industry should carefully analyse the proposed changes and consider whether a submission is appropriate. The proposals concerning SaMD and AI disclosure requirements are particularly significant to the regulation of advertising of digital health.

[1] The consultation paper is available here.