AusBiotech had made a submission to the Senate Inquiry on the Therapeutic Goods Amendment (2016 Measures No. 1) Bill 2016, urging that the Bill be supported to enable regulatory reform measures stemming from the review of Medicines and Medical Devices Regulation (MMDR).
AusBiotech supports the MMDR’s regulatory reforms and efforts to reduce costs and administrative burden for industry, making the assessment process shorter and simpler, while maintaining the safety and quality of medicines and medical devices.
The Review’s recommendations that won Government support were sensible and supported by stakeholders – from consumers to industry - and are expected to provide industry with annual savings of around $75 million through the reduction in unnecessary red tape and regulation on the pharmaceutical and medical device industries, while maintaining safety and integrity of the regulatory process.
New pathways for the priority approval
The Bill contains provisions for a “regulation-making power to set out the details of new pathways for the priority approval of medicines and medical devices and biologicals that are fully-evaluated for safety- quality and efficacy or performance” in order to facilitate quicker patient access to new medicines and devices that have significant advantages over existing treatments.
The details of the new pathway arrangements are yet to be determined and are the subject of extensive and proper consultation, prior to the specific regulations being finalised.
Conformity assessment of medical devices
The Bill also supports the recommendation for the conformity assessment of medical devices to occur in Australia by private bodies designated by the TGA. It provides a regulation-making power to allow the Secretary to designate bodies in Australia to appraise the suitability of the manufacturing process for devices manufactured in Australia, and to assess whether such devices meet minimum standards of safety and performance.
In principle, AusBiotech supports the MMDR panel’s Recommendation 15(2) that a body designated by the TGA be able to undertake Conformity Assessment of medical devices for the Australian market.
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. These reforms, which are supported by stakeholders, have been more than a decade in discussions, two years in review and AusBiotech urges the Senate Inquiry to support these much-needed reforms.
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 without comprising safety.
The full AusBiotech submission can be found online.
More information about the Senate Inquiry can also be found online.