Sep 16, 2016
EMERGO SUMMARY OF KEY POINTS:
Responding to a series of new medical device and pharmaceutical regulatory reform proposals, the Australian government has expressed support for more than one pathway to market authorization in order to boost patient and user access to new devices.
The proposals follow an assessment of Australia’s current drug and medical device regulatory system starting in late 2014 by a government-commissioned expert panel. The Australian Department of Health officially responded to 58 panel recommendations.
Among recommendations for improving the Therapeutic Goods Administration (TGA) oversight of medical devices, the panel proposed establishing three major market pathways for manufacturers to commercialize their products in Australia:
The government has officially accepted these recommendations, stating that implementing multiple market pathways would “streamline access to medical devices for consumers, provide additional flexibility for sponsors, and is consistent with the Government’s regulatory reform and contestability agendas.”
The Department of Health plans to implement “early opportunities” of the expert panel’s recommendations in 2016 and 2017, according to its official response.
The medical device regulators of Australia, Brazil, Canada and the US have all signed on to a statement of cooperation to develop a single audit program for medical devices to be used by all four market authorities.
Upon implementation of the MDSAP program, the audit of a medical device manufacturer’s quality system in any one of the four participating countries will meet regulatory requirements of all four countries—a significant move that could ease medical device company’s paths to market in these regions.
The Australian Department of Health recently issued several corrections to its list of prosthetic medical devices used to determine reimbursement rates from private health insurers in the country.