No more ANZ therapeutic products regulator

The Australian and New Zealand governments have ceased efforts to establish a joint therapeutic products regulator, the Australia New Zealand Therapeutic Products Agency (ANZTPA). The agency stemmed out of an agreement between the two governments in December 2003 to regulate medicines (including complementary medicines) and medical devices.

The decision to cease the scheme was taken following a comprehensive review of progress and assessment of the costs and benefits to each country of proceeding. Each country will now proceed with its own domestic therapeutics regulatory reform program but will remain open to future cooperation activities.

Australia’s Therapeutic Goods Administration (TGA) and the New Zealand Medicines and Medical Devices Safety Authority (Medsafe) - the developers of the scheme - will explore other trans-Tasman regulatory harmonisation activities that represent potential value to both countries and build upon earlier business-to-business projects. These include the development of a new information-sharing agreement and formalising mutual recognition of good manufacturing practice audits, which will increase the potential for regulatory alignment over time to reduce compliance costs.

Australia and New Zealand will continue to cooperate on the regulation of therapeutic products where there are mutual benefits for consumers, businesses and regulators in each country.

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