Regulatory News

Consultation is focused on the reform themes of preparedness, response, recovery, funding, workforce and operational capability and capacity, and legislation and regulation.

 

A discussion paper provides more information on the reforms proposed under these themes. Visit the National Biosecurity Reform Have Your Say to view the discussion paper and participate. This will be open for submissions until 5pm AEST, 12 June 2026

hare your feedback on the department’s documentation requirements for imported goods.

The Inspector-General of Biosecurity (IGB) is reviewing the department’s documentation requirements used in the biosecurity risk assessment of imported goods.

This review will examine whether current documentation requirements:

• support high-quality and consistent biosecurity risk assessments

• are efficient, clear, and practical

• show a clear link between each requirement and the biosecurity risks being managed.

The IGB is seeking feedback from importers, customs brokers and other stakeholders who interact with documentation requirements for the biosecurity clearance of

We invite you to share your experiences with current documentation requirements, including how you interpret and comply with them. Your feedback will help us understand what works well and identify areas of improvement.

Have your say

To share your feedback about departmental documentation requirements:

• read the Review work plan

• take our survey by answering questions or uploading a document.

Submit your feedback by 5 pm (AEST) on Friday 22 May 2026.

 

Reviewing documentation requirements for imported goods - Department of Agriculture, Fisheries and Forestry

May 2026

     

 

 

 

 

Cost Recovery and Sustainable Funding of the Gene Technology Regulatory Scheme Budget 2026/27

The government has agreed to increase OGTR funding by $6.8 million over 4 years from July 2026, and $1.7 million per year ongoing from 2030-31 to provide sustainable funding for Australia’s Gene Technology regulatory scheme. The funding will also enable a transition from fully government funded to a partial user pays system with the phased introduction of cost recovery.

The initial phase of cost recovery is based on existing legislative authority and will cover licence and facility certification applications. As part of the government’s ongoing commitment to supporting research and innovation, all purely research activities will be exempt from licence application costs. Applications for commercial licences will be charged at 50% of actual costs and 25% for pre-commercial work such as clinical trials and field trials.

Phase 2 will require changes to the Gene Technology legislation and will expand cost recovery to all application types received by the OGTR. This will ensure costs are spread fairly across all users and not just licence holders. However, exemptions and exclusions will remain in place to protect those with limited ability to pay.

• The funding boost will enable the gene technology regulatory scheme to respond effectively to increased demands resulting from fast paced innovation and increasing product delivery in the gene technology sector.
• Sustainable funding delivers effective risk management and compliance, enables innovation and productivity, and ensures safeguards for all Australians.
• Robust and sound regulatory safeguards support national security and assist innovative biomanufacturing, sustainable agriculture and clinical trials leading to cutting-edge lifesaving medical treatments.
• Timely and responsive regulation provides regulatory certainty to attract industry investment and enable Australian manufacturing of vaccines.

 

Questions and Answers

Why is the OGTR receiving more funding?

• Advances in science and innovation have significantly increased the demand for, and complexity of, gene technology authorisations. This demand has continued to accelerate across a range of sectors in Australia, particularly vaccines and other medicines.
• The OGTR has received addition funding to meet this increased demand and ensure regulatory services remain fit for service. This represents the first increase in base funding since 2002.

Why is the OGTR introducing cost recovery?

• The gene technology scheme has been funded by government for nearly 25 years. It now requires a sustainable funding model to continue to operate efficiently into the future.
• Cost recovery was anticipated at the start of the scheme but delayed due to a lack of maturity of the sector and limited applications of gene technology at the time. The focus was on regulating the research sector without stifling innovation.
• More recently there is increasing use of biotechnology for manufacture of therapeutics, human and animal vaccines manufacture, gene therapies and sustainable agriculture for food production.
• A shift towards translation of biotechnology in different sectors and a move towards commercial activities means it is feasible to commence cost recovery.

What is the basis for introducing cost recovery?

• The activities undertaken by the OGTR fall within the scope of the Australian Government Charging Framework.
• A 2022-2023 Department of Health Portfolio Charging Review recommended that cost recovery be implemented in a phased approach, commencing with current legislative provisions.

Who will be affected?

• Gene technology is a diverse and broadly defined sector, including:

• Small research groups and universities,
• Hospitals and research institute,
• Small biotech start-up companies through to large, multinational corporations.

• The sector has made important contributions to society, particularly through advancements in agriculture and medicines.
• All levels of Australian government, regulators, research bodies and universities, biotechnology industry companies, including agribusiness and pharmaceutical companies, consumers and the general public will benefit from enhanced regulatory performance and regulatory certainty.

How are research activities impacted?

• Stakeholder consultation was undertaken in developing models and costing options, while noting the concerns of the research community. Exemptions for licence applications for those undertaking research activities have been agreed by government.
• A phased approach towards implementation of cost recovery within current legislative settings will assist in alleviating cost shocks for those undertaking pre-commercial activities.

Will there be time for regulated entities to adjust to cost recovery?

• Yes. Because this is a significant change for the sector, there will be further consultation on a Cost Recovery Implementation Statement and the development of regulations prior to the commencement of cost recovery.

What activities will be cost recovered?

• In the initial phase we will be charging for licence applications involving commercial and pre-commercial (clinical and field trials) work with GMOs, but pure research licence applications will still be paid for by government. We will also be charging for facility certification applications and introducing an annual fee for licences.
• In phase 2 cost recovery will be expanded to cover all application types and further annual fees. Stakeholder consultation will be ongoing through all stages and will be used to ensure all charges remain appropriate.

Next Steps

• OGTR will be preparing a Cost Recovery Implementation Statement (CRIS) for public consultation. This will set out the proposed fees and charges for phase one. This consultation is expected to occur by the end of this calendar year.
• We will also form an industry reference group with representatives from the gene technology sector to provide ongoing stakeholder input on cost recovery.
• The OGTR website will be updated with more information as it becomes available.

 

Please check our website, or subscribe to OGTR News for updates relating to the regulation of gene technology.

The Gene Technology Bill proposes a new regulatory framework in New Zealand to enable the safe use of gene technologies and regulated organisms. It aims to modernise oversight, support innovation, and ensure risks to human health, the environment, and cultural values are appropriately managed.

The Bill is currently undertaking its second reading before proceeding to the Committee of the Whole House. To read the Bill, please click on the link below.

If you would like to raise any concerns or provide commentary, please Contact us or email us at admin@absanz.org.au

Gene Technology Bill 110-1 (2024), Government Bill Contents – New Zealand Legislation

 

he Australian standard, AS 2252.4:2010 Controlled environments, Part 4: Biological safety cabinets and Classes I and II has been updated and a draft of the revised standard is now available for public comment.

Key changes include:

• Overall alignment of the document to the current terminology and format of other documents in the AS 2252 series.
• Updated terminology in line with both AS 2252 and AS 2243 series.
• Modified and updated requirements for the sitting of a device.

Further information, a copy of the draft standard and the consultation site through which individual comments can be submitted can be found here.

Consultation closes on the 22 April 2026.

The Gene Technology Implementation Team is seeking feedback on proposed amendments to the Gene Technology Regulations.

These amendments include significant changes to authorization pathways and nomenclature. ABSANZ encourages all members to review the proposed changes and provide their feedback. 

Further information, including the consultation paper, consultation questions and a link to the consultation hub where you can submit your feedback can be found here.

Additionally, the presentation slides from the information session the Gene Technology Implementation Team held in February are available here.

Consultation closes on the 1 March 2026.

Alternatively, you can Contact us with your feedback and our Regulatory Liaision Committee will submit a response on behalf of our membership. 

Do you have a young, budding biosecurity officer or are you involved in teaching the next generation?

The Department of Agriculture Fisheries and Forestry is seeking feedback on classroom resources developed for primary school teachers and students in years 2-5 as part of its Junior Biosecurity Officer program.

The resources and feedback surveys can be found here.

• DAFF Australia – have selectively released public comment for BC5.2 Conditions minor updates. This comment period has closed, and they are updating conditions for publication.
• OGTR released their proposed PC2 conditions for targeted public comment earlier this year and is in the process of updating the conditions for publication.
• AS/NZS 2982 Laboratory Design – Currently out for public comments

 

CH026 - Laboratory

AS/NZS2243 Safety In Laboratory  (these parts are all due for review in 2026)

Part 1 (general)

Part 4 (ionizing radiation)

Part 5 (non ionizing radiation)

Part 8 (ducted fume cupboards)

 

Standards Australia and Standards New Zealand have signed a new Standards Development and Distribution Agreement and Standard Operating Procedures, marking a major step forward in modernising and streamlining the development and maintenance of joint trans-Tasman standards, and the harmonised adoption of international standards together.

For further information please click on link to website New trans-Tasman agreement to strengthen Single Economic Market - Standards Australia