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The Therapeutic Goods Administration (TGA) has reset its compliance agenda for the next two years, and the message is clear: expect sharper, faster and more digitally focused regulation.
A change in strategy
Moving away from a narrow product-specific approach, the TGA has introduced five overarching compliance principles that apply across all regulated therapeutic goods:
- safeguarding therapeutic goods
- educating to empower
- protecting those most at risk
- leveraging digital capability, and
- strengthening enforcement.
This shift reflects a move towards a broader, principle‑based and risk‑focused framework, signalling a more agile approach to compliance and enforcement. The TGA has highlighted a particular focus on online advertising, social media and influencer marketing, as well as the need to respond proactively to emerging digital and technological risks.
Priority focus areas
Alongside its new compliance principles, the TGA has identified 12 priority focus areas for compliance and enforcement activity:
- direct-to-consumer IVD kits
- erectile dysfunction medications
- foetal dopplers
- listed medicine advertising
- medical cannabis
- melatonin
- software as a medical device
- substandard and falsified goods
- sunscreens
- weight loss medications
- therapeutic goods used in cosmetic procedures, and
- vaping goods.
These priority areas will be reviewed quarterly and adjusted in response to emerging risks. They operate alongside the TGA’s broader Regulatory Compliance Framework, which outlines how the TGA promotes compliance and addresses breaches of the Therapeutic Goods Act 1989 (Cth).
Implication for the life sciences industry
While it remains to be seen how the updated compliance focus will play out in practice, life sciences companies should expect increased and more proactive scrutiny of digital advertising, social media activity and online marketing practices, particularly within the identified priority focus areas.
It is also noteworthy that many of the specified products are those which have faced recent media scrutiny and/or are increasingly before the courts for product liability, healthcare liability, and competition and consumer law issues.
Organisations should take the opportunity to reassess advertising approval processes, Australian Register of Therapeutic Goods listings, labelling accuracy and internal governance frameworks, particularly where products or services fall within the TGA’s priority focus areas.
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.
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