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University of Queensland Press




Pharmaceutical regulatory agencies struggle worldwide to maintain public trust these days. Drug safety issues proliferate,' the costs of lharmaceuticals take increasingly larger shares of most countries' health service spending, and conflicts of interest afflicting the drug approval and marketing processes capture more and more public attention. The Australian and New Zealand governments are keenly aware of these problems, and have been attempting to forge a regulatory alliance to combine their respective pharmaceutical regulatory agencies, Australia's Therapeutic Goods Administration (TGA) and New Zealand's Medicines and Medical Devices Safety Authority (Medsafe), into the pending Trans Tasman Therapeutic Products Authority (ANZTPA, or TPA). If this effort succeeds, it could serve as a model of cost-effective regulatory cooperation for the rest of a transparency-seeking world to emulate. If it does not, a unique opportunity to merge national pharmaceutical regulatory operations to cope more effectively with 21st century global realities will have been lost.

Writing about Australia and New Zealand's pending regulatory consolidation has its surreal aspects, particularly from afar, since as of this writing the whole venture hangs on passage of enabling legislation still mired in distant political maneuvering. 5 Perhaps some observations about the accomplishments and shortcomings of two well-known pharmaceutical harmonization schemes from other areas of the world, both of them less comprehensive than the merger envisioned for ANZTPA, can illuminate why the pending joint venture holds so much promise for Australia and New Zealand.6 Cooperative efforts such as those of the European Union's European Medicines Agency (formerly the European Medicines Evaluation Agency, and still known by the acronym EMEA) 7 and the International Conference on Harmonization (ICH), an inter-continental government/industry-sponsored organization dedicated to a achieving a more transparent regulatory approach among the world's three major pharmaceutical-consuming areas (the EU, the U.S. and Japan),8 offer an illuminating preview of the problems and prospects associated with harmonizing the often-disparate national policies, cultural issues and ethical approaches inevitably involved when attempting to regulate therapeutic products in a cooperative context.

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