Advertising therapeutic products

In 2002, a review of advertising therapeutic products in Australia and New Zealand was undertaken to develop an advertising scheme, including approval and complaints processes, that could be adopted as part of a trans Tasman therapeutic products agency. A wide range of stakeholders in Australia and New Zealand were consulted during the course of the review and the final report <http://www.tga.gov.au/docs/html/advrev.htm> is now available.

Clinical trials & unapproved therapeutic goods

The TGA and the National Health and Medical Research Council have initiated a review to examine the current regulatory provisions for clinical trials and access to unapproved therapeutic goods in Australia and New Zealand. The review will also assess international practices in comparable countries for their relevance and applicability to Australia and New Zealand.

Further information <http://www.tga.gov.au/docs/html/cltrialrev.htm>, including terms of reference, Steering Committee membership and contact details, are available on this website.

Fees & charges

A summary of fees and charges applicable from 1 July 2003 and explanatory notes <http://www.tga.gov.au/docs/html/feesach.htm> are available on this website.

Human tissues and emerging biological therapies

In 2002, the Australian Health Ministers Conference agreed to the TGA introducing a national regulatory framework for human tissues and emerging biological therapies. Ministers also agreed that the therapeutic goods legislation be amended to accommodate therapeutic goods manufactured from viable human or animal tissue.

A Discussion Paper was developed and workshops were held during April and May 2003 to provide stakeholders with an opportunity to make comments about the issues raised in the Discussion Paper.

The consultation period has now closed.

National Drugs and Poisons Schedule Committee

The NDPSC has changed its website address. NDPSC information may now be accessed from <www.tga.gov.au/ndpsc>.

Over the last few months, the NDPSC has:

• released information on Australian State and Territory regulatory controls on Schedule 7 poisons <http://www.tga.gov.au/ndpsc/s7juris.htm>
• made minor editorial changes to the Guidelines for the National Drugs and Poisons Schedule Committee <http://www.tga.gov.au/ndpsc/ndpscg.htm>
• published pre-meeting and post-meeting gazette notices <http://www.tga.gov.au/ndpsc/ndpscgan.htm> and the February 2003 record of reasons <http://www.tga.gov.au/ndpsc/records.htm>.

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Medical device/medicine "borderline" products

During March and April 2003, the TGA sought comments on a proposal to change the way a number of "borderline" medical device/medicine products are regulated, including haemodialysis solutions and IVF media. The consultation period has closed.

Stakeholders will be advised if any regulatory changes occur.

Surveillance news

In May 2003, the TGA successfully took action against an individual in Queensland for illegally exporting therapeutic goods. The man was convicted on 42 counts of illegally exporting therapeutic goods and was fined a total of $21,000. The Court also ordered the forfeiture of $90,000 worth of blood glucose test strips seized by the TGA.

In April 2003, Curacel International Pty Ltd was fined a total of $84,000, having been convicted of manufacturing counterfeit medicines, carrying out unlicensed steps in the manufacture of medicines, and manufacturing and supplying unapproved medicines. The Company Director was also fined $12,000 for his involvement in label swapping of over the counter preparations. The company's manufacturing licence was cancelled by the TGA in June 2001.

SUSDP No.18

The Standard for the Uniform Scheduling of Drugs and Poisons (SUSDP <http://www.tga.gov.au/ndpsc/susdp.htm>) contains the decisions of the National Drugs and Poisons Schedule Committee (NDPSC) regarding the classification of drugs and poisons into Schedules for inclusion into the relevant legislation of the States and Territories.

SUSDP 18, effective date 2 May 2003, is available for purchase.

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Tamper-evident packaging

During April and May 2003, consultation was undertaken on the draft Code of Practice for the Tamper-Evident Packaging (TEP) of Therapeutic Goods.

It is proposed that compliance with the Code of Practice for the Tamper-Evident Packaging (TEP) of Therapeutic Goods will become mandatory under therapeutic goods legislation with effect early 2004, with a one-year transition period during which sponsors will need to ensure compliance.

Trans Tasman agency

After several years of policy development and negotiations, the Australian and New Zealand governments have agreed to establish a single trans Tasman therapeutic products agency to regulate medicines and medical devices. The initiative will harmonise the regulation of therapeutic products between both countries under the Trans-Tasman Mutual Recognition Arrangement.

From 1 July 2005, the joint agency will replace the Australian Therapeutic Goods Administration (TGA) and the New Zealand Medicines and Medical Devices Safety Authority (Medsafe). The new agency will be accountable to the Australian and New Zealand governments, have its ongoing funding cost recovered from industry, and will safeguard public health and safety through regulation of the quality, safety and efficacy of therapeutic products.

The joint agency represents a significant step in bilateral trade relations and aims to deliver, to both sides of the Tasman greater flexibility, wider choice and lower business compliance costs through harmonisation of therapeutic product standards.

An Australia and New Zealand project team will continue to work on the final details of the regulatory framework and the legislation underpinning the joint agency, the treaty between Australia and New Zealand, and the transition arrangements. Stakeholders will continue to be consulted on these proposals and, in particular, on transition arrangements as the opening of the agency draws closer.

Transmissable Spongiform Encephalopathies (TSEs)

The document Supplementary Requirements for Therapeutic Goods for Minimising the Risk of Transmitting Transmissable Spongiform Encephalopathies (TSEs) <http://www.tga.gov.au/docs/html/tsesupp.htm> has recently been updated.

It outlines a self-assessment process whereby sponsors of therapeutic goods can collate information necessary to certify compliance with the TGA requirements to minimise TSE transmission risks.

The implementation date for the revised document was 30 June 2003.

TGA recalls

Two consumer-level medicine recalls (one involving over 1600 products) and two consumer-level medical device recalls have occurred since the last issue of TGA News. For more information see Product Recalls <http://www.tga.gov.au/recalls/index.htm>.

TGA website

The TGA website has a new address: <www.tga.gov.au>. The old address will still work for a short time but you should start using the new address now.

The TGA has recently conducted a review of its website. The review involved focus groups, user tests and an Internet survey. As a result of the review, there will be some noticeable changes made to the website over the coming months. Thank you to all who participated.