Submissions

AusBiotech is committed to representing the Australian life science ecosystem and regularly seeks feedback from its members and Advisory Groups, who are key stakeholders of the sector’s industry, research and investment counterparts.

AusBiotech regularly submits commentary on behalf of its members and the Australian life science industry, addressing topics such as the R&D Tax Incentive, intellectual property, medical devices and diagnostics, prostheses listing, agriculture and foodtech. Our commentary is submitted to the Therapeutic Goods Administration (TGA), Productivity Commission, Department of Industry, Science, Energy and Resources, FSANZ and other relevant bodies.

Recent AusBiotech submissions

Date Topic Submission Title Submitted to
November 2025 Horizon Europe Possible association to Horizon Europe: Request for information Department of Industry, Science and Resources
October 2025 National Health and Medical Research Strategy Draft National Health and Medical Research Strategy consultation Department of Health, Disability and Ageing
September 2025 Strategic Examination of R&D (SERD) AusBiotech response to consultation on Issues Papers Department of Industry, Science and Resources
September 2025 Australian Centre for Disease Control Bill 2025 AusBiotech Submission to the Community Affairs Legislation Committee Community Affairs Legislation Committee
July 2025 Economic Reform Roundtable submission AusBiotech and Medicines Australia submission to Economic Reform Roundtable Federal Treasury
April 2025 Strategic Examination of R&D AusBiotech Submission to Strategic Examination of R&D Department of Industry, Science and Resources
31 January 2025 Federal Budget

Pre-Budget Submission 2025-26: AusBiotech and MTPConnect

Federal Treasury
31 January 2025 Federal Budget Pre-Budget Submission 2025-26: AusBiotech and Medicines Australia – Australian Life Sciences Council Federal Treasury
31 January 2025 Federal Budget Pre-Budget Submission 2025-26: Cell and Gene Catalyst Federal Treasury
31 January 2025 Federal Budget Pre-Budget Submission 2025-26: AusBiotech, Medical Technology Association of Australia and Medicines Australia – National One Stop Shop Federal Treasury
02 April 2024 NSW Innovation Blueprint AusBiotech submission in response to the NSW Innovation Blueprint – Discussion Paper Investment NSW
23 February 2024 HTA Cell & Gene Catalyst submission in response to the Health Technology Assessment Policy and Methods Review - Consultation 2 Department of Health and Aged Care
23 February 2024 Fees & Charges AusBiotech submission in response to the TGA fees and charges proposal 2024-25 consultation paper Therapeutic Goods Administration
25 January 2024 Clinical trials The Research & Development Taskforce's National One Stop Shop Pre 2024-25 Federal Budget Submission The Treasury
16 October 2023 Cell & gene therapies Australia's Cell & Gene Catalyst's response to the Unleashing the Potential of our Healthcare Workforce – Scope of practice review Department of Health and Aged Care
16 October 2023 RNA technologies AusBiotech's response to the Understanding our RNA potential: discussion paper Department of Industry, Science and Resources
8 September 2023 Regulation AusBiotech submission in response to Draft guidance on requirements for Class 4 in-house IVDs used for screening faecal microbiota transplant (FMT) donors Therapeutic Goods Administration
15 August 2023 Prostheses List AusBiotech submission in response to the Prostheses List Reforms Consultation Paper 7 - Proposed measures for compliance, assurance and information sharing Department of Health
28 July 2023 SME support AusBiotech's submission in response to the Industry Growth Program Department of Industry, Science and Resources
14 July 2023 Funding AusBiotech's submission in response to Improving alignment and coordination between the Medical Research Future Fund and NHMRC’s Medical Research Endowment Account Department of Health and Aged Care
16 March 2023 Fees & Charges AusBiotech's submission in response to the TGA Fees and Charges Proposal 2023-2024 consultation paper Therapeutic Goods Administration
9 February 2023 Understanding and complying with advertising rules for therapeutic goods AusBiotech's submission in response to draft guidance for therapeutic goods advertising and ASX announcements Therapeutic Goods Administration
3 February 2023 Manufacturing AusBiotech's submission in response to the National Reconstruction Fund consultation paper Department of Industry, Science and Resources
27 January 2023 TGA Funding AusBiotech's joint submission for Securing sustainable funding for the Therapeutic Goods Administration The Treasury
27 January 2023 Regulation

AusBiotech's response to the 'TGA Learn' consultation

Therapeutic Goods Administration
26 September 2022 Regulation AusBiotech's joint submission to the TGA's proposed regulatory changes for clinical trials for medical devices Therapeutic Goods Administration
25 March 2022 Regulation AusBiotech's response to Priority Review Pathway for Biologicals: feasibility, potential eligibility criteria and determination process Therapeutic Goods Administration
4 March 2022 TGA's Fees and charges

AusBiotech's response to the TGA's Fees and charges 2022 - 2023 proposal

Therapeutic Goods Administration
25 February 2022 Prostheses List AusBiotech submission in response to the Prostheses List Reforms - Consultation Paper No. 3 - A modernised fit-for-purpose listing process Department of Health
17 February 2022 R&D Tax Incentive AusBiotech's submission in response to the Draft Industry Research and Development (R&D Tax Incentive on clinical trials, Phase 0, I, II, III for an unapproved therapeutic good) Determination 2021 Department of Industry, Science, Energy and Resources
1 December 2021 Manufacturing cell and gene therapies

Presenting to the Inquiry into the Australian Manufacturing Industry: AusBiotech's speech is available on Hansard, and Further Questions on Notice are available here.

Economics References Committee
15 October 2021 Commercialisation AusBiotech's joint response to the Higher Education Research Commercialisation (HERC) IP Framework. Department of Education, Skills and Employment
10 September 2021 Manufacturing cell and gene therapies AusBiotech's joint submission to the Economics References Committee’s Inquiry into the Australian Manufacturing Industry Economics References Committee
16 August 2021 Patent Box AusBiotech's response to the Australian Patent Box: Treasury Discussion Paper on Policy Design. Treasury
9 April 2021 Commercialisation AusBiotech's response to the Department’s University Research Commercialisation consultation paper Department of Education, Skills and Employment
17 March 2021

Gene technology

AusBiotech's response to the Department of Health's consultation on: Modernising and future-proofing the National Gene Technology Scheme Department of Health
15 February 2021 Prostheses List AusBiotech's response to the Department of Health's Consultation Paper: Options for reforms and improvements to the Prostheses List Department of Health

View other submissions

Contact AusBiotech for submissions prior to 2012.