AusBiotech to submit on TGA Amendment Bill Senate Inquiry


The Senate has referred the most recent TGA Amendment Bills for Inquiry, delaying the implementation of a raft of recommendations of the Medicines and Medical Devices Regulation Review (MMDR).

The implementation planned for January 2018, was subject to the passage of amendments to the Therapeutic Goods Act and Regulations, which are now the subject of the Inquiry.

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.

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.

On 30 November 2017, the Senate referred the Therapeutic Goods Amendment (2017 Measures No.1) Bill 2017 and the Therapeutic Goods (Charges) Amendment Bill 2017 to the Senate Community Affairs Legislation Committee for inquiry and report. 

The ‘Measure’ bill amends the Therapeutic Goods Act 1989 to:

  • introduce a new approval pathway for prescription medicines by creating a class of therapeutic good to be known as ‘provisionally registered goods’;
  • allow the minister to specify, by legislative instrument, permitted indications for use with listed medicines;
  • establish an additional pathway for intermediate risk medicines through a new application and assessment process for sponsors of listed complementary medicines seeking to use indications that fall outside the permitted indications list;
  • strengthen monitoring powers in relation to biologicals; implement stronger compliance and enforcement powers and graduated penalties for non-compliant behaviours; remove the distinctions between advertisements for therapeutic goods for which an approval is, or is not, required; enable the secretary to utilise the work of comparable overseas regulators in the course of making assessments of medical devices;
  • enable the secretary to publish information in relation to Australian conformity assessment bodies;
  • align the secretary’s powers relating to conformity assessment certificates issued by Australian conformity assessment bodies and conformity assessment certificates issued by the secretary;
  • clarify that the secretary has the power to refuse an application for including medicines, biologicals and medical devices in the Australian Register of Therapeutic Goods prior to evaluating the application if it does not meet the application requirements;
  • and make minor amendments to achieve consistency of regulatory requirements between different types of therapeutic goods and make other minor changes; and Broadcasting Services Act 1992to make consequential amendments.

The closing date for submissions is 12 January 2018. AusBiotech members are invited to submit comment for inclusion in its submission to Lorraine Chiroiu, Deputy CEO of AusBiotech ( 9828 1400) by 6 January 2018.

Full details on the inquiry are available online.