24 October 2014.
The Generic Medicines Industry Association (GMiA) welcomes the government’s announcement of an expert review of medicines and medical device regulation in Australia.
GMiA acting CEO, Belinda Wood said “Today’s announcement recognises that there are efficiencies to be gained in the regulation of medicines. Improving the efficiency of the Therapeutic Goods Administration (TGA) processes will reduce duplication and the regulatory burden on medicine manufacturers, and result in Australian patients being able to access more affordable generic medicines sooner.”
GMiA members operate in the global context and recognise the work to date of the TGA to work cooperatively with regulators in other jurisdictions. Removal of Australian-specific regulatory requirements, international work-sharing and more efficient use of TGA resources will result in more efficient access to affordable medicines, encourage competition and deliver ongoing savings to the Pharmaceutical Benefits Scheme (PBS).
“With our member base supplying more than 90% of generic prescription medicines dispensed in Australia, GMiA looks forward to working with the expert panel, providing them with constructive solutions to ensure the regulatory framework balances safety and market access to benefit Australian patients.” said Ms Wood. ENDS.