Upcoming Rules in Australia to Allow Earlier Access to Medical Devices
The Australian government announced it will allow earlier access to investigational devices under new regulations that the Therapeutic Goods Administration plans to roll out in the next few years.
The Ministry of Health said the government will adopt most of the recommendations from an independent review of the country’s drug and device regulations in 2014.
The reforms include improving access to medical devices by expediting approval, particularly for products already approved in comparable countries such as the U.S. and the European Union.
The independent review found that Australian patients get access to innovative products up to 15 months later than patients in the U.S. and EU.