Fees & charges

Changes to the TGA's fees and charges regulations for the commencement of the 2005-06 financial year have been delayed.

Until further notice, the TGA's fees will remain at the 2004-05 level.

• Fees for applications received prior to the date of effect of the new regulations will not be amended.
• Fees for applications received after the date of effect of the new regulations will require the applicable 2005-06 fee to be paid.

It is important that sponsors and manufacturers check the TGA website for the applicable fee prior to making an application.

Note that annual product charges will be processed in October using the applicable annual charge for the 2005-06 financial year.

• TGA fees and charges <http://www.tga.gov.au/docs/html/feesach.htm>

NDPSC update

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

The NDPSC meeting and gazettal dates have been updated.

Recalls

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

The list of Recall Coordinators in the Uniform Recall Procedure for Therapeutic Goods <http://www.tga.gov.au/docs/html/urptg.htm> (URPTG) has been updated.

TGO

Therapeutic Goods Order No. 73 Standards for haematopoietic progenitor cells derived from cord blood has been registered with the Federal Register of Legislative Instruments (FRLI) and is now in force.

Trans Tasman joint agency

As part of the formation of the Joint Agency, the Therapeutic Products Interim Ministerial Council established a committee of experts to make recommendations on standards to be applied to therapeutic products. The composition and terms of reference for this committee can be found on the JTA Project website <http://www.anztpa.org/committees/jieacs.htm>.

The first meeting of the core members of this committee was held on 7 June 2005 in Sydney. The committee was briefed on the establishment processes for the joint agency and on the current situation relating to standards for therapeutic products in Australia and New Zealand.

The committee discussed a range of issues relating to standards and agreed on the priorities for further actions. A workplan was developed that involves specialist subcommittees to address key issues such as the default standard to be applied to medicines under the new agency.