The Expert Committee on Complementary Medicines in the Health System

Following the recall of over 1,600 complementary medicines in April 2003, the Australian Government established the Expert Committee on Complementary Medicines in the Health System to reassure the public and maintain confidence in Australia's reputation as a supplier of high quality and safe medicines.

The Committee was asked to consider the regulatory, health system and industry structures necessary to ensure that the objectives of the National Medicines Policy (NMP) were met in relation to complementary medicines. In particular, the Committee was asked to advise on the regulatory controls covering appropriate standards of quality, safety and efficacy of complementary medicines, education and training of healthcare practitioners, and the maintenance of a responsible and viable complementary medicines industry in Australia.

In considering its terms of reference, the Committee recognised three fundamental principles: firstly, the need to protect public health and safety; secondly, the primacy of the right of consumers to be able to make informed choices on matters of healthcare; and thirdly, the ethical responsibilities of all healthcare providers.

In order to be in a position to bring forward an informed response to the Committee's findings and recommendations, the Hon Trish Worth MP, Parliamentary Secretary to the Minister for Health and Ageing, released the Committee's report on 31 October for wide stakeholder consultation. The consultation period will be open until the end of January 2004. The report and details regarding the consultation process <http://www.tga.gov.au/docs/html/cmreport.htm> are available on this website.

Release of ELF 3

On 15 September 2003, the TGA released a new system for listing medicines on to the Australian Register of Therapeutic Goods (ARTG). The new system - Electronic Lodgement Facility 3 (or ELF 3 as it is more commonly known) - has replaced the previous version of ELF and has been developed with the aim of streamlining market access for sponsors of listed medicines while enhancing the TGA's post market monitoring and review capabilities.

ELF 3 has been designed and developed by the TGA in consultation with industry over the past four years.

As ELF 3 is accessed via the Internet, the rules and restrictions can be maintained by the TGA in real-time and kept constantly up-to-date, providing sponsors with access to the latest regulatory requirements relating to listed medicines.

To coincide with the release of ELF 3, the TGA is providing sponsors of listed medicines a 3 month period in which they can update, re-validate and re-certify information relating to their currently listed medicines on the ARTG free of charge.

This re-validation and re-certification period provides a unique opportunity for sponsors of listed medicines to make changes, without charge, to their products' ARTG record, to ensure that the information recorded on the ARTG is true, correct and fully compliant with all legislative requirements.

ADEC 40th anniversary

The first Australian Drug Evaluation Committee (ADEC) meeting was held on 25 July 1963. The role of ADEC was then, and continues to be, the provision of independent, scientific advice on new drugs, within the policy framework of the time, to the Federal Government.

A dinner was held on 7 August 2003 to celebrate the achievements of the committee over the past 40 years. Terry Slater, National Manager TGA, was the master of ceremonies and the Hon Trish Worth MP, Parliamentary Secretary to the Minister for Health and Ageing, delivered the keynote speech.

More information on the ADEC 40th anniversary dinner <http://www.tga.gov.au/docs/html/adec/40thdinner.htm> is available on this website.