Member representation continued over festive break


Submission preparation continued over the December/January break with AusBiotech lodging one submission in late December and two lodged so far in the New Year, including a response to the Senate Inquiry into the TGA ‘Measures’ Bill.

AusBiotech’s response to Sunsetting of the Therapeutic Goods Regulations and Therapeutic Goods (Medical Devices) Regulations was prepared by the AusMedtech Regulatory Affairs Expert Panel (Regulatory Panel) and submitted in late December.

The Regulatory Panel is a subcommittee of AusMedtech chaired by Grant Bennett, providing expert advice on operational and policy-related regulatory matters.

AusBiotech said in the submission it was of the opinion that mandatory “sunsetting” of the Therapeutic Goods Regulations and the Medical Devices Regulations will adversely affect the existing regulatory framework, and cause unnecessary disruption to the commercial operations within the medtech sector.

In early January, AusBiotech provided comment on the Senate Inquiry, with perspectives from the life sciences industry, in regard to the Therapeutic Goods Amendment (2017 Measures No.1) Bill 2017 and the Therapeutic Goods (Charges) Amendment Bill 2017, and urged that the Bills 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 Bills form 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 overall are supported by stakeholders, have been more than a decade in discussions, two years in review and now more than a year in implementation.

This week AusBiotech has lodged a response to the TGA’s draft policy on the provision of electronic instructions for use (eIFU) for professional users of medical devices (including IVDs). Again led by the Regulatory Panel, the submission responds to numerous elements of the discussion paper.

All submissions can be accessed online at the AusBiotech website.