15 September 2016
MTPConnect has welcomed the Federal Government’s response to the independent expert panel Review of Medicines and Medical Devices Regulation.
The response to the Review’s 58 recommendations identifies ways to improve access to therapeutic goods for consumers, and to remove red-tape for industry, while upholding safety, in line with the sector growth priorities identified in the MTPConnect Draft 10-year Sector Competitiveness Plan.
Through greater flexibility and accelerating approval and priority evaluation pathways to access earlier data sets as well as life-saving and innovative medicines and medical devices – developed and assessed by regulatory bodies both within the local and international markets – consumers and those within the sector together will benefit from reduction in duplication and greater efficiency. The resulting rapid and early access to lifesaving, innovative, medicines and devices will greatly assist the medtec, biotech and pharmaceutical sector in Australia to grow to its productive commercial potential.
Specific decisions to defer consideration of recommendations to establish high-risk implantable device registries, and rejection of the delegation of decision-making to a single person (the Chief Medical Officer), have also been welcomed as actions that will contribute to faster approval processes and managing additional costs that would disadvantage smaller players in the sector.
CEO of MTPConnect, Sue MacLeman, acknowledged the response as another step forward in advancing the Australian sector, complementary to MTPConnect’s vision of maximizing competitiveness and productivity to achieve more rapid and sustained growth.
“The government’s response goes a long way to streamlining the regulatory burden felt by the sector, creating opportunities for greater collaboration and R&D innovation,”
“We look forward to working collaboratively with the sector and Government to assist in further consultation and the implementation of these beneficial measures over the next three years.”