Australia-US free trade agreement

Amendments to the Therapeutic Goods Act 1989 for the purpose of implementing obligations under the Australia-US Free Trade Agreement took effect on 1 January 2005. These amendments apply to applications for the registration or listing of a therapeutic good (other than devices) under section 23 of the Act, made on or after 1 January 2005.

For more information and copies of the approved certificates see: Australia-US Free Trade Agreement <http://www.tga.gov.au/international/usfta.htm>.

Cosmetics/therapeutic goods interface

In May 2004, stakeholders were invited to participate in a review of the policy framework for regulating products at the cosmetic / therapeutic interface.

Following extensive consultation in Australia and New Zealand, the outcome of the review has been released as a draft discussion paper that is open for comment <http://www.tga.gov.au/consult/2005/cosmeticrepdr.htm> before a final report is published. This document is available on the TGA, joint agency project and NICNAS websites.

The closing date for comment is 5 May 2005.

IVth IABs Symposium

As part of its mission to promote discussion of contemporary issues related to biological medicinal products for human and veterinary uses, the International Association for Biologicals (IABs) holds a biennial Symposium on Advances in Transfusion Safety. The next symposium will be held at Olympic Park, Homebush, NSW, 11-13 October 2005.

NDPSC update

Gazette notices <http://www.tga.gov.au/ndpsc/ndpscgan.htm> associated with the October 2004 and the February 2005 meetings of the National Drugs and Poisons Schedule Committee and the record of reasons <http://www.tga.gov.au/ndpsc/record/rr200410.htm> for the October 2004 meeting are available.

Recalls

One consumer-level medicine recall <http://www.tga.gov.au/recalls/index.htm> has occurred since the last issue of TGA News.

The Uniform Recall Procedure for Therapeutic Goods <http://www.tga.gov.au/docs/html/urptg.htm> (URPTG) has been updated and the 2004 edition is now available.

TGC update

The 24th meeting report and resolutions from the 25th and 26th meetings <http://www.tga.gov.au/docs/html/tgcminu.htm#y2004> of the Therapeutic Goods Committee (TGC) are available.

Trans Tasman joint agency

The Australian and New Zealand Governments have agreed to defer for a year the start-up of the new Trans-Tasman therapeutic products agency to ensure the new regulatory scheme is world class and recognising the importance of consulting with industry, consumers and other interested parties.

The Parliamentary Secretary for Health, Christopher Pyne, announced in February that the new agency will be operational on 1 July 2006, although if the scheme is ready before then, it could start earlier.

The media release <http://www.health.gov.au> is available on the Department of Health and Ageing website.

22nd NRL Workshop on Serology

The 22nd NRL Workshop on Serology will be held on 2-5 August 2005 at the Hilton Adelaide in South Australia. See the NRL website <http://www.nrl.gov.au> for more details.