Annual regulatory symposium on blood safety and sufficiency

The Annual Regulatory Symposium on Blood Safety and Sufficiency is to be held in Melbourne on 19 August 2002 in conjunction with the 19th NRL Workshop on Serology on 20-22 August 2002.

This symposium is jointly organised by the TGA and the Paul-Ehrlich-Institut, Germany's regulatory body responsible for blood safety. It will feature national and international speakers and will include sessions on:

• Blood safety regulatory measures in Australia and Europe
• Scientific state-of-the-art updates on pathogens transmitted by blood
• Optimal blood screening strategies, including nucleic acid testing
• The risk of variant CJD
• Development of optimal blood usage guidelines
• Issues associated with stem cells and leucocytes.

This important event aims to provide a forum for regulatory agencies and other organisations interested in infection safety of blood and blood products to learn the latest developments in these areas.

Review of drugs, poisons and controlled substances legislation

In July 1999, the Council of Australian Governments (COAG) commissioned a Review of all State and Territory drugs, poisons and controlled substances legislation against the Principles of National Competition Policy. Ms Rhonda Galbally (Managing Director of the Australian Health Institute) chaired the Review. The Review undertook extensive public consultation with a wide range of stakeholders.

In December 2000, the final report <http://www.tga.gov.au/docs/html/rdpdfr.htm> was presented to the Australian Health Ministers' Conference (AHMC).

The Terms of Reference of the Review require Australian Health Ministers to prepare comments for COAG on the Review's recommendations. As agreed by the Commonwealth and all States and Territories, this Response is to be prepared in consultation with the Primary Industries Ministerial Council (PIMC). This is because some of the recommendations of the Review may affect how the primary industry sector is regulated.

A Working Party, chaired by the Commonwealth, was established in February 2001 to assist Health Ministers with the task of preparing this Response. Considerable progress has been made, and the consultation with the Primary Industries Ministerial Council is now being undertaken.

Once final comments are received, the draft Response will be finalised and provided to the Australian Health Ministers' Advisory Council for consideration and referral to the AHMC. Australian Health Ministers will then forward their final Response, together with the Review Report, to COAG.

Therapeutic Goods Committee 20th meeting report

The 20th meeting of the Therapeutic Goods Committee was held on 16 April 2002. The main outcomes of the meeting were recommendations for:

• The undertaking of broad consultation on an amended draft of Therapeutic Goods Order No. 65 Child-Resistant Packaging for Therapeutic Goods
• Revocation of the current Australian Codes of Good Manufacturing Practice for Therapeutic Goods - Medicinal Products (August 1990) and Medicinal Gases (July 1992), and the Investigational Medicinal Products Code of GMP, and the adoption as a Manufacturing Principle in Australia of the Pharmaceutical Inspection Co-operation Scheme (PIC/S) document Guide to Good Manufacturing Practice for Medicinal Products (Revision 3 dated 15 January 2002), with a 12-month transition period to apply; and that the TGA and the Industry Associations develop appropriate education programs and information material
• Revocation of Therapeutic Goods Order No. 29 Standards for Ethanol, with 12-month transition arrangements to be applied by the TGA
• Consideration of key stakeholder comments on the addition of Amendment 1 to British Pharmacopoeia 2001 to the edition of the British Pharmacopoeia defined under the Therapeutic Goods Act 1989 out-of-session during May 2002
• In-principle support for the consolidation of all mandatory label requirements, including all mandatory warning statements, into the Labelling Order (Therapeutic Goods Order No. 69 General requirements for labels for medicines or its successor) with a target effective date of 1 July 2004
• Amendment of Therapeutic Goods Order No. 66 Standards for Blood Components to update, to the 8th edition, the definition of the Council of Europe document Guide to the preparation, use and quality assurance of blood components, applied as the Australian standard for fresh blood components.

The recommendations of the Therapeutic Goods Committee are yet to be considered by the TGA.

It is expected that the next Meeting of the Therapeutic Goods Committee will be held in October 2002.

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Trans Tasman harmonisation

The Australian and New Zealand Governments have agreed in-principle to establish a single trans-Tasman therapeutic goods agency, subject to an agreed position on its details.

In February 2002, the Australian Government considered a submission on the trans-Tasman proposal and approved further work to be done on the joint agency's institutional design, governance, accountability arrangements and regulatory framework.

Following consultation with a range of stakeholder groups, including industry and consumer representatives and professional associations, Australian and New Zealand officials have developed proposals for implementing a joint agency for the regulation of therapeutic products (including prescription, OTC and complementary medicines, and medical devices). These proposals are presented in a recently released discussion paper.

As part of a communication strategy for the trans-Tasman agency, a joint agency website <http://www.anztpa.org> has been developed to keep stakeholders up-to-date and informed on progress towards a joint agency. A copy of the discussion paper can be accessed on either the joint agency website or the TGA website.

It is expected that a final decision on whether to proceed with the establishment of a joint agency will be made by the Australian and New Zealand Governments in the second half of 2002. If a joint agency is to be established, work will proceed on developing new legislation to be introduced to Parliaments in 2003. The earliest date for commencement of a joint scheme is expected to be mid-2004.

The TGA's Trans Tasman Group will continue to work with stakeholders in further refining the proposals over the coming months. Subject to a final decision from both Governments to proceed with the establishment of a joint agency, draft legislation and technical orders will be developed and further input from stakeholders will be sought as this process continues.

For more information regarding the project, the TGA's Trans Tasman Group can be contacted on 02 6232 8184 or by email at Trans.Tasman@tga.gov.au.

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What's new in advertising

New email address

To further improve our customer service, the Advertising Unit now has a central email address tga.advertising@tga.gov.au. To ensure a rapid response, all email correspondence should be sent to this address.

Advertising information on the Internet

The TGA Internet site has been updated to include information about:

• Advertising therapeutic goods to consumers
• How to lodge complaints about advertisements for therapeutic goods
• Schedule 1 certificates
• Gazettal notices relating to advertisements.

More information: Advertising therapeutic goods <http://www.tga.gov.au/advert/index.htm>