AusBiotech backs TGA Bill to cut red tape

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AusBiotech backs regulatory reform and the reduction in the burden of 'red tape', expressing support for The Therapeutic Goods Amendment (2016 Measures No. 1) Bill 2017, which is currently before the federal parliament.

The Bill will enable implementation of a number of outcomes from the Review of Medicines and Medical Devices Regulation (MMDR), also known as the 'Sansom Review'.

The review outcomes were almost entirely adopted by government and are expected to provide industry with annual savings of around $75 million through the reduction in red tape and regulation on the pharmaceutical and medical device industries. 

AusBiotech CEO, Mr Glenn Cross, said: “AusBiotech’s extensive advocacy, especially in regard to third party conformity assessment and expedited pathways for approval, will benefit the industry with less confusion and red tape, speed, education, and efficiency, and get products to patients more quickly while maintaining safety.” 

The Bill’s passage will support reduced costs and administrative burden for industry, with the assessment process shorter and simpler, while maintaining the safety and quality of medicines and medical devices. The number of committees that advise the TGA will be reduced.

The Review, conducted by an independent expert panel, made 32 recommendations in its first report covering six main areas, the majority of which were supported in the 2016-17 Budget.

AusBiotech’s initial submission to the Review was made in January 2015, however the Industry has been advocating for many of these improvements for a decade.

“The Bill forms an important step in the realisation of regulatory reform for the approval of medicines and medical devices in Australia and long-awaited improvements to the environment for the development of new health technologies,” added Mr Cross.