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Joint statement regarding ANZTPA

Joint statement by Hon Peter Dutton MP, Minister for Health for Australia, and Hon Dr Jonathan Coleman, Minister of Health for New Zealand, regarding ANZTPA

The Hon Peter Dutton MP, Minister for Health for Australia, and the Hon Dr Jonathan Coleman, Minister of Health for New Zealand, today announced their governments’ agreement to cease efforts to establish a joint therapeutic products regulator, the Australia New Zealand Therapeutic Products Agency (ANZTPA).

The decision was taken following a comprehensive review of progress and assessment of the costs and benefits to each country of proceeding.

While work on ANZTPA will cease, our two countries will continue to co-operate on the regulation of therapeutic products where there are mutual benefits for consumers, businesses and regulators in each country.

Australia’s Therapeutic Goods Administration (TGA) and New Zealand’s Medicines and Medical Devices Safety Authority (Medsafe) will continue to explore other trans-Tasman regulatory harmonisation activities that represent potential value to both countries, and that 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. This work will increase the potential for regulatory alignment over time to reduce compliance costs.

Each country will now proceed with its own domestic therapeutics regulatory reform programme but we remain open to future cooperation activities. Ministers will continue their bilateral engagement, including through New Zealand’s participation in the Council of Australian Governments (COAG) Health Council.

ends

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