The passage of a legislative bill to enable regulatory reform measures stemming from the review of Medicines and Medical Devices Regulation (MMDR) was last week delayed with its referral for Inquiry.
The Senate has referred the Therapeutic Goods Amendment (2016 Measures No. 1) Bill 2016 to the Senate Community Affairs Legislation Committee for inquiry and report. The submissions due date has not yet been set, but the reporting date is 27 March 2017.
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 implementation of the Review’s recommendations, especially those concerning third party conformity assessment and expedited pathways, is expected to reduce red tape and regulation on the pharmaceutical and medical device industries, providing industry with savings of around $75 million per annum.
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 consultation, prior to the specific regulations being finalised.
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.
“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,” said AusBiotech CEO, Mr Glenn Cross.
The Inquiry is now open for submissions and details can be found online.