Legislation

Bill to reform Australia's Therapeutic Goods Act in parliament

The reform agenda drawn up by Australia's Therapeutic Goods Administration to streamline the regulatory framework for medical devices has been introduced in parliament^1-3. The Therapeutic Goods Amendment (Medical Devices and Other Measures) Bill 2008, which was presented before the Senate on 3 December, amends the existing Therapeutic Goods Act 1989 in a number of ways.

The bill principally implements improvements that were identified during talks on the development of the Australia-New Zealand Therapeutic Products Authority, which is now on hold. The bill is the first in a package of reforms and will be followed by further legislative amendments.

The amendments expand the range of 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. It also offers clarity on the “fit and proper person” test that relates to grant of manufacturing licences with the aim of reducing unnecessary regulatory requirements.

The bill also allows the government, acting in the national interest, to exempt medical devices from the requirements of the act so that these products can be sourced from manufacturers who do not regularly supply goods to the Australian market, and do not have TGA approval. The provision allows the government to create a stockpile of devices, such as face masks and injection kits, for use in an emergency.

References

1. TGA, What's New: Regulatory Reform, 3 December 2008, www.tga.gov.au/regreform/index.htm#intro

2. Hansard, 3 December 2008, http://parlinfo.aph.gov.au/parlInfo/download/chamber/hansards/2008-12-03/toc_pdf/6446-2.pdf;fileType=application%2Fpdf#search=%22THERAPEUTIC%20GOODS%20AMENDMENT%20(MEDICAL%20DEVICES%20AND%20OTHER%20MEASURES)%20BILL%202008%22

3. The Regulatory Affairs Journal - Devices, 2008, 16(6), 405-406