Australia: regulatory reform at TGA

The Australian government has agreed to implement a reform agenda to update and streamline the existing regulatory framework for therapeutic goods. This will focus on a wide range of reforms that were developed and consulted on as part of the legislation associated with the proposed Australia New Zealand Therapeutic Products Authority. Consultations for each therapeutic product sector were held in late-July and early-August.

This month, the Therapeutic Goods Amendment (Medical Devices and Other Measures) Bill 2008 was introduced to the Senate by Senator Jan McLucas. In terms of pharmaceuticals, the bill will: clarify the "fit and proper person" test and ensure it is applied more effectively and directly to matters relevant to manufacturing therapeutic goods in Australia. In clarifying this test the TGA aims to reduce any unnecessary regulatory requirements; adopt the European or US Pharmacopoeia as additional default standards under the Act; expand the range of therapeutic goods information that can be released to the public and provide a wider range of circumstances where the TGA can release information to Commonwealth agencies or international authorities to support safety and quality in therapeutic goods; and apply more consistency to the regulation of advertisements in all media.