TGA is undergoing changes in response to a ‘Functional and Efficiency Review’ of the Department of Health – there is now a ‘Regulatory Service Group’ that includes TGA, the Office of Gene Technology Regulator and the Office of Chemical Safety. There is also a new Regulatory Performance Framework with KPIs that the TGA’s performance will be measured against. The first report is due in the second half of 2016.
How to overcome resistance to biosimilars that are now being listed on the Pharmaceutical Benefits Scheme in order to reap the financial benefits for the taxpayer is an issue for Government. This topic will be addressed as part of a PBS Access and Sustainability Package just announced, with $20 million funding for 2015-18.
by Dr. Richard O. Day, DIA Fellow; DIA Global Forum Regional Editor: Australia/New Zealand; Professor of Clinical Pharmacology, St. Vincent’s Hospital, Australia