Australia Takes Step Toward Establishing ANZTPA

Australia's Department of Health and Ageing has posted a draft version of the Australian Therapeutic Products Bill on its website for consultation.

In 2003 the Australian and New Zealand governments signed a treaty to establish a joint drug regulatory body, the new Australia New Zealand Therapeutic Products Authority (ANZTPA).

The Australian and New Zealand governments will both pass legislation to establish ANZTPA and its regulatory powers. The Australian Therapeutic Products Bill is the first piece of legislation.

The bill establishes the ability of ANZTPA to administer the joint products regulatory scheme, provides for the governance and accountability of the authority and establishes civil and criminal sanctions that apply in Australia for breaches of the scheme.

Australia also plans to implement two other bills, one that provides for the consequential amendments and transitional arrangements related to the establishment of ANZTPA and another establishing the charges regime under ANZTPA.

To view the bill and submit comments, go to www.health.gov.au/internet/wcms/publishing.nsf/Content/therapeutic-products-lp-1#docs1 ( http://www.health.gov.au/internet/wcms/publishing.nsf/Content/therapeutic-products-lp-1#docs1 ).