Australia – Australia Looks to Improve Generic Drug Authorization Process

Australia’s Therapeutic Goods Administration (TGA) announced Thursday that it’s considering a range of options to improve the generic medicine registration process.

Chief among those options is TGA’s consideration to allow the use of overseas reference product in bioequivalence studies, as currently the reference product used in such studies must be an existing medicine approved in Australia.

“Our requirements are largely consistent with comparable overseas regulatory agencies, such as those in Europe and Canada. However, some agencies such as those in Switzerland and Singapore, do not always rely on the same way of demonstrating ‘identicality,’” TGA says…