Australia and New Zealand Agencies Announce Workflow Ahead of Planned Merger

Posted 02 February 2012 | By Alexander Gaffney, RAC 

Australia's Therapeutic Good Administration (TGA) and New Zealand's Medicines and Medical Devices Safety Authority will be merged in to a single regulatory body in the next five years, according to a statement released by TGA on 28 January.

The new regulatory body will have "the objective of ensuring that consumers have access to safe, quality medicines and medical devices which are brought to market through a single approval process for both countries," TGA said in a statement.

Shared resources will allow for "rigorous evaluation", more effective surveillance of products and economic efficiencies that will benefit both countries.

The partnership will start co-developing projects beginning with the launch of an information website on adverse drug reactions in July 2012. Additional cooperation this year will include improved search functions for adverse drug reactions, a common recalls portal and a common early warning system.

Further efforts this year will also focus on how the two agencies can merge their application, assessment, evaluation and registration processes.

By 2013, the two agencies should have "established an integrated capability to conduct audits to assess good manufacturing practice (GP)," and will start sharing their good manufacturing practice reports by the end of 2012.



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