DRW Monthly
December 2006
Issue No. 1

Welcome to the first issue of DRW Monthly! We are pleased to be able to provide you with coverage of topics of global importance to healthcare and regulatory affairs professionals. Subscribers are encouraged to provide comments on articles as well as suggestions for topics they would like to see addressed.

Review of Joint Regulatory Scheme for Proposed Australia New Zealand Therapeutic Products Authority (ANZTPA)

The Australian and New Zealand governments entered into the second phase of consultation last month on the proposed trans-Tasman regulatory scheme for therapeutic products. This phase of the project will focus on developing the final details associated with the proposed regulatory framework including the legislation that will reinforce the joint agency, the treaty between Australia and New Zealand and the transitional arrangements to create a new agency. The initial dialogue between New Zealand and Australian government officials to consider a joint medicines regulatory body began in 2001. It was not until 10 December 2003, however, that the governments signed an agreement to establish a joint regulatory scheme for therapeutic products. The new agency will replace the Australian Therapeutic Goods Administration and the New Zealand Medicines and Medical Devices Safety Authority and assume responsibility for the regulatory functions currently performed in both countries.

The treaty between the two countries will establish a two-member Ministerial Council comprising the New ZealandMinister of Health, the Australian Health Minister and a five member Board that will be responsible for the agency's strategic direction and financial management. One of the Board members, the managing director, will be responsible for regulatory decisions about therapeutic products and the agency's day- to-day operations. The Ministerial Council will appoint the Board and the managing director. The framework for the regulatory scheme administered by the agency will be set up under the treaty and implemented through Acts of Parliament in both countries.

The primary objective of the proposed joint regulatory scheme is to protect the health and safety of Australians and New Zealanders by regulating the safety, quality and effectiveness of prescription and over-the-counter medicines, complementary medicines, medical devices, tissue and cellular therapies, and blood and blood products in both countries. The agency will employ a risk-based approach to assess the regulatory requirements to be associated with the products under review. The key activities of the agency will be to conduct pre-market evaluation and assessment; to license products; to implement manufacturing controls; to perform post-market monitoring and surveillance; and to set standards. It is hoped that the establishment of a trans-Tasman agency will lead to closer cooperation between countries and regulators in the Asia-Pacific region.

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