Australia, New Zealand cancel agreement for joint therapeutic regulator

Friday, November 21, 2014

Peter Dutton, MP, Minister for Health for Australia, and the Jonathan Coleman, Minister of Health for New Zealand, have 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. While work on ANZTPA will cease, the two countries will continue to cooperate on the regulation of therapeutic products where there are mutual benefits for consumers, businesses and regulators.

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 harmonization 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 formalizing mutual recognition of good manufacturing practice audits. This work will increase the potential for regulatory alignment over time to reduce compliance costs.

Each country now will proceed with its own domestic therapeutics regulatory reform program, but will 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.

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