World Self-Medication Industry, 4th Asia Pacific Regional Conference - Regulators' Forum

In November 2000, the Therapeutic Goods Administration (TGA) held a Regulators' Forum in conjunction with the World Self-Medication Industry (WSMI), 4th Asia Pacific Regional Conference in Sydney.

The Forum was chaired by the TGA National Manager, Mr Terry Slater, and brought together representatives from Australia, Canada, the European Commission, Fiji, Indonesia, Japan, Korea, Myanmar, Nepal, New Zealand, Philippines, Singapore, Taiwan, Thailand and Vietnam. In addition to government regulators, there were industry representatives and a consumer advocate at the table, with 120 invited guests acting as observers.

The Forum was designed to develop a regional approach to foster closer collaboration in the region between the regulatory authorities and lead towards increased harmonised approaches in the regulation of therapeutic goods.

The following presentations were given at the Forum:

• Australia and New Zealand - the proposed trans-Tasman Therapeutic Goods Agency, presented by Dr Stewart Jessamine (New Zealand) and Graham Peachey (Australia),
• How the proposed trans-Tasman Therapeutic Goods Agency model measures up with European models, presented by Mr. Patrick Deboyser,
• Regulation of OTC products in Canada, presented by Dr Robert Peterson,
• Australian Office of Complementary Medicines - Managing the risks, presented by Dr Fiona Cumming, and
• Regulation of therapeutic goods - a consumer's perspective, presented by Ms Janne Graham.

These presentations were followed by reports from the regulators outlining notable events in therapeutic goods regulation in their countries. The Forum also prepared the 'Sydney 2000 Declaration'. The Declaration was prepared by drawing on the key principles underpinning good regulatory practice and pointed towards future collaboration between Regulators in the region. Each participant was given the opportunity to provide comments on the wording of the Declaration. The debate surrounding the wording was a highlight of the day with participants enjoying the opportunity to freely exchange ideas regarding the future of regulation in the region. The final content of the Declaration was unanimously agreed to.

The Forum is seen as a significant first step in solving some of the problems facing regulators, such as collaboration on the use of Internet technology and enhancing and promoting reasonable choice through truthful and valid advertising of self-medication products.

The success of the Forum has highlighted the TGA's position as a regional leader for therapeutic goods regulation. It has also greatly increased the level of cooperation and understanding between stakeholders such as the self-medication industry and consumers.

It is expected that the Declaration will be reconsidered at the next Asia Pacific Regional Regulators' Forum to be held in Tokyo in 2002.

A transcript of the Forum will be available shortly.

Incorporation of the Australian Therapeutic Device Bulletin into TGA News

The Australian Therapeutic Device Bulletin (ATDB) has been combined with TGA News. News articles in relation to medical devices can be found under the Medical Devices heading.

The ATDB Incident Report Investigation Scheme (IRIS) news and safety alerts will be included as an insert in the 2001 issues of TGA News. These can also be found on the internet under the IRIS News and Safety Alerts heading.

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For any further queries please contact the TGA Publications Office on 1800 020 653.