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Nanotechnology and therapeutic products

9 July 2008
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The term nanotechnology is used to describe a wide range of methods involved in the production and engineering of structures and systems by controlling size and shape at the nanometre scale.

When used in therapeutics, nanotechnologies have been defined as the application of nanotechnologies (or nanomedicine) for the purpose of making a medical diagnosis or treating disease.

Therapeutic products containing nanomaterials in the form of metal oxides, liposomes, polymer protein conjugates, polymeric substances and suspensions have been registered in Australia and/or marketed overseas in the United States or the European Union. Information about the safety of nanomaterials in sunscreens is available on the TGA website.

The use of nanotechnologies in therapeutics may offer benefits to the patient including increased efficacy in treating the disease and reduced side effects. For example, this may be possible by better targeting of a medicine to a specific location in the body.

There is currently no evidence to suggest that therapeutic products which incorporate nanotechnologies pose greater safety risks than conventional products.

Prior to approval for marketing in Australia, the sponsor of a therapeutic product must submit or hold substantive scientific evidence demonstrating the quality and safety of that product.

Therapeutic goods are regulated as the end product with each product available for sale considered to be a separate and distinct good and regulated individually. Any change to the composition or form of that product that influences the safety of the product creates a new product and/or requires reassessment. The TGA is committed to ensuring that this remains true for all product classes in the face of an increased application of nanotechnologies.

To date, the existing regulatory framework of the TGA has proved more than adequate to identify, assess and manage the risks associated with therapeutic products that incorporate nanotechnologies.

However, the TGA recognises that the development of nanotechnologies, as well as other technologies, will continue to pose challenges to regulators into the future.

The best response to such challenges is the maintenance and continued development of high quality scientific expertise within the agency together with ongoing interaction with sponsors, researchers, regulators and policy makers throughout Australia and internationally, to which the TGA is committed.

As such, the TGA is conducting a comprehensive review of current regulatory arrangements to ensure that those arrangements remain adequate to assess and manage the risks that may be associated with products manufactured using increasingly sophisticated nanotechnologies.

The TGA is also continuing to closely monitor developments around nanotechnology internationally to ensure a rapid response to any new issues identified.