IVD Australia welcomes scientist as Head of TGA

IVD Australia, the industry body representing manufacturers and sponsors of pathology tests, has congratulated Dr John Skerritt on his appointment as the new National Manager of the Therapeutic Goods Administration (TGA).

“We are delighted to have someone with Dr Skerritt’s background and ability leading the TGA at this important time and we look forward to working with him in the future,” said Dr Peter Harman, CEO of IVD Australia.

“His background in diagnostics and pharmacology is especially welcome with the transition period for IVDs reaching its midpoint shortly.”

Dr Skerritt is currently the Deputy Secretary of the Department of Primary Industries in the Victorian Government. He holds a PhD in Pharmacology and is an adjunct Professor at the University of Queensland. He will join the TGA at the end of May.

The appointment has come at a somewhat tumultuous time, with IVD Australia currently expressing concern over the IVD Regulation Transition period, regulation and validation of laboratory developed tests, the TGA’s proposal for fee increases of over 5.5% for the 2012/13 year as well as the ongoing Medical Device Reform agenda.

“The principal concern, at present, is that significant numbers of higher risk (Class 3 and 4) IVDs will be not transitioned to the new regulatory framework due to the substantial costs and resources required to obtain Australian Register of Therapeutic Goods (ARTG) inclusion. This will mean they will no longer be supplied to the Australian market post 30 June 2014,” said Dr Harman. “We are working with the TGA to identify where this may cause issues for laboratories.”