The Commonwealth Health Department has formed a new Regulatory Services Division – bringing together TGA along with industrial agricultural chemicals, veterinary medicines and gene technology regulation.
In a letter to stakeholders earlier this week, TGA national manager John Skerritt – who takes on the new role of Deputy Secretary Regulatory Services – with leadership responsibility for the entire group of agencies – explained the changes.
Most significantly there will also be a wholesale reorganization of TGA along product lines – with new Medical Devices and Drugs divisions. This is a return to the old days of the Drugs and Devices Branches. The 2010 TGA21 experiment of functional groupings has been buried.
The reorganisation integrates TGA much more closely into the Health Department, and will include centralisation of many of the corporate service and IT functions. This raises interesting challenges for TGA’s cost recovery model – where it will be interesting to see how the necessary cross charging arrangements for services shared with other regulatory agencies and the health Department more generally will be managed in order to keep clear separation of industry fee and commonwealth funding of the regulator.
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