Therapeutic Goods Administration (Australia)

The Therapeutic Goods Administration (TGA) is the statutory body responsible for regulating therapeutic goods in Australia. “Therapeutic goods” include both therapeutic substances (medicines) and medical devices. The TGA is a unit of the federal Department of Health and Ageing, and is responsible for ensuring the safety of such products and devices containing engineered nanoparticles. These presently include, for example, pharmaceuticals, sunscreens, and drug delivery systems.

In order to ensure the quality, safety, and efficacy of therapeutic goods, the TGA is vested with extensive pre-market and postmarketing powers under the Therapeutic Goods Act (1989). These include the authority to undertake premarket human risk assessment on certain classes of goods and postmarketing monitoring. In performing these functions, the TGA does not differentiate between products on the basis of whether or not they are nanotechnology based, but rather by virtue of the category of good. The TGA's legislative framework requires that claims for a “listable good” are supported by scientific evidence. The regulator is not required to verify the efficacy of a listed good prior to its entry on the Australian Register of Therapeutic Goods. Evaluation of this class of good by the TGA, however, may occur once it has been supplied in Australia, and in response to, for example, human health and safety concerns.

Sunscreens provide a useful example to elucidate the TGA's role with respect to nanoparticles. Sunscreens with a sun protection factor of 4 or above are currently considered by the TGA to be a “low risk” category of therapeutic good or “listed medicine.” Such goods are evaluated on the basis of their quality and safety and regulated accordingly. Efficacy is not, however, evaluated by the TGA prior to its entry onto the market regardless of the size of its active ingredients. Given suggestions of the potential risks posed by topically applied products containing insoluble or biopersistent engineered nanoparticles, some commentators have suggested that the current approach to regulating “low risk” good represents a gap within the TGA's regulatory framework.

The TGA has however been vigilant in monitoring scientific developments associated with nanotechnologies and therapeutic goods. It has reviewed the safety literature on titanium dioxide and zinc oxide nanoparticles in sunscreens, actively participated in the National Nanotechnology Strategy's Health, Safety and Environment Working Group, has reviewed the adequacy of its own regulatory framework, and has also participated in a number of national and international forums.

It would therefore appear that the TGA's risk-based regulatory framework is sufficiently flexible to effectively manage potential human health and safety risks posed by therapeutic goods incorporating nanotechnologies. With such goods likely to become increasingly sophisticated, however, the TGA will nonetheless need to continue to evaluate its regulatory framework in light of the available scientific literature.