In December 20, 2003 the Australian and New Zealand Governments signed a treaty to establish a single, bi-national agency to regulate therapeutic products, including medical devices and prescription, over-the-counter and complementary medicines, as part of “Globalisation and the way “Towards a harmonised regulatory pathway”. [2, 3, 4]
“Harmonisation of therapeutic products regulation is a relatively recent development, but there are ongoing activities at both the global and regional levels, as well as numerous formal and informal bilateral arrangements. For example, a number of states have chosen to recognise approvals by the United States FDA, either de jure, through a formal agreement, or de facto“.
“The single agency, which will replace the Australian Therapeutic Goods Administration (TGA) and the New Zealand Medicines and Medical Devices Safety Authority (Medsafe), will be accountable to both the Australian and New Zealand Governments. It is expected that the same regulation in force in Australia will also apply to New Zealand as per the amended law.” [1]
If the bi-national regulator is “implemented, the joint agency could serve as a model that would usefully inform initiatives in other jurisdictions”. On January 12, 2012 the “Australia New Zealand Therapeutic Products Agency (ANZTPA)” had their “first meeting” following June 20, 2011 agreement to proceed, and completed a “harmonisation activity”. But on November 20, 2014 the Oceania Regulator ANZTPA was officially scrapped. [5]
Harmonisation is still alive. The FDA is a founding member of International Conference on Harmonisation, on March 26, 2020 encouraged the “pharmaceutical regulatory authorities globally” to implement the ICH Guidelines to achieve International Regulatory Harmonization.