1. Agricultural Chemicals Directors’ update: Dr Gary Dorr and Dr Heidi Mitchell

Welcome to the January 2026 edition of the Australian Pesticides and Veterinary Medicines Authority’s (APVMA) Agricultural Chemicals Regulatory Newsletter.

In this edition we have included information on a variety of regulatory topics for our applicants and stakeholders, such as an introduction to the new science leaders for the APVMA, updated guidance on using reference products, an update on the APVMA’s chemical review of anticoagulant rodenticides, and the EPAC2026 Conference.

We encourage applicants to participate in APVMA stakeholder meetings, which are a valuable forum for both industry and the APVMA to discuss current and future applications, priorities, and to work through any concerns. These meetings can be organised through your Case Manager by emailing casemanagement@apvma.gov.au. Please reach out via the Enquiries Team if you require assistance related to the registration of pesticides.

If you have any suggestions or requests for future editions of this Newsletter, please send them through to communications@apvma.gov.au.

2. Agricultural Chemicals Working Group

The Agricultural Chemicals Working Group provides a forum for the APVMA, peak bodies and regulated entities to discuss a range of operational matters related to the regulation of agricultural chemicals. This group aims to enhance the transparency of APVMA processes, improve regulatory efficiency, and ensure that industry perspectives are considered.

The second meeting of the Agricultural Chemicals Working Group was held on 3 December 2025. The group discussed the existing low burden pathways for Agvet chemical regulation, including prescribed, listed and reserved registration pathways. The group also discussed the importance of minor use pathways and agreed that improving minor use would be an area of focus for the Working Group.

If you are interested in joining the group please express interest in joining the Agricultural Chemicals Working Group.

3. APVMA performance update

The APVMA has updated how we report on our performance, in our new performance report for Quarter 1 of the 2025–26 financial year.

In Q1, the APVMA completed 1,505 activities related to regulatory decisions, including 463 product registrations / permits and 17 emergency permits. We completed 99 compliance investigations, 23 manufacturing audits, and processed 781 adverse experience reports.

For Agricultural Chemical applications, we completed:

  • 76.6 % of total Agricultural Chemical product applications within timeframe
  • 58.9 % of Agricultural Chemical product major applications within timeframe.

We will continue to refine our performance reporting, and welcome feedback on our updated performance report through to Engagement@apvma.gov.au.

4. Useful information for industry

This edition’s useful information for industry covers:

4.1. New science leaders for the APVMA

The APVMA recently welcomed 3 outstanding executives to lead its new science branches:

  • Dr Ed Cram, Executive Director of Agricultural Chemicals
    • The Agricultural Chemicals branch oversees the pre-market regulation of agricultural chemical products. It covers all of the pre-market scientific assessment and risk management activities, including Registration, Permits, Chemistry and Manufacture, Efficacy and Safety, Environment, Health, and Residues and Trade.
  • Lee Metcalf, Executive Director of Veterinary Medicine
    • The Veterinary Medicine branch is responsible for pre-market regulation of veterinary chemical products. It is divided into Registration and Permits, Chemistry and Manufacture, Efficacy and Safety and Health, Residues and Trade.
  • Dr Maria Trainer, Executive Director of Science and Assurance
    • Dr Maria Trainer has served in an executive role at the APVMA for more than 7 years. She now oversees Chemical Review, Manufacturing Quality and Licensing (MQL) and Assurance, Science Policy and Capability. She also leads international engagement efforts, shapes operational policy, and develops guidance to support regulatory clarity and scientific integrity.

Additional information regarding our new science leadership can be found on our website.

4.2. Update on applications using reference products

The APVMA released updated guidance on using reference products to satisfy the statutory criteria. This new guidance applies to all applications that rely on a reference product and is presented in one location to help applicants navigate the process more efficiently.

The new guidance builds on the APVMA’s update on expectations around what data must be held on reference products in the update on application requirements for ‘closely similar’ item 6 and 7 applications published 11 June 2025.

The APVMA contacted applicants with applications that were in progress on 11 June 2025 that relied on reference products to discuss next steps. Applicants can withdraw their application and request a refund of the original application fee, and are encouraged to submit a new application in line with the updated guidance. If you have an application that is affected and you have not heard from us, please contact casemanagement@apvma.gov.au.

4.3. External Scientific Reviewers

The APVMA is seeking to expand its pool of External Scientific Reviewers (ESRs) to support the scientific assessment of agricultural chemical products.

As an ESR, you will be engaged under contract to independently assess technical information submitted by applicants. These assessments may relate to:

  • new product registrations
  • variations to existing approvals
  • chemical reconsiderations (reviews) undertaken to ensure that registered products continue to meet contemporary scientific standards.

This is an opportunity to contribute to the regulation of chemical products used across Australia’s agvet sectors, and to play a direct role in maintaining the safety and effectiveness of these products in the market.

If you are interested in joining the pool of ESRs, more information is available on the APVMA website.

4.4. APVMA chemical review of anticoagulant rodenticides

On 16 December 2025, the APVMA published information regarding its risk assessments of anticoagulant rodenticides. The APVMA has proposed substantial changes to the products in this category, to ensure the safety of people and the environment, especially native birds and mammals. These changes were enacted through 2 different regulatory mechanisms: 

  • The proposed suspension of products containing second-generation anticoagulant rodenticides (SGARs).
  • Proposed reconsideration decisions, which include a wide range of restrictions on the use of all anticoagulant rodenticide products, and the cancellation of specific products that pose an unacceptable risk.

Public consultation on the proposed reconsideration decisions is currently open, and will close on 16 March 2026.

Further information regarding the proposed decisions is available in the Anticoagulant rodenticides Review Technical Report, and the APVMA Special Gazette, 16 December 2025.

4.5. EPAC2026 Conference

The APVMA will be hosting the conference EPAC2026 – an international conference on Advancing Sustainability in Agriculture: Enabling Precision Application of Crop Protection Products by Inclusion in Regulatory Approaches (Processes), sponsored by the Organisation of Economic Co-operation and Development (OECD) Co-operative Research Programme. 

The conference will take place over 2 days at the Melbourne Convention Centre on 19 and 20 February 2026 and will be attended by experts from key sectors including:

  • national and international regulators
  • leading researchers and equipment manufacturers
  • the crop protection industry and growers.

The programme will bring together the perspectives of each sector and explore what is required to support precision application technologies within regulatory frameworks. The recommendations arising from this conference will be provided to the OECD and help shape a future programme of work in this area.

Whilst virtual tickets are now sold out, tickets are still available for in-person attendance. The outcomes of the event will be published. For further information please visit the EPAC2026 website.

4.6. Lodging applications for registration or variation that rely on an Item 25 assessment outcome

The APVMA may provide a technical assessment of data under an Item 25 application; these are provided under regulation 8AS of the Agricultural and Veterinary Chemicals Code Regulations 1995, defined as ‘If a person applies to the APVMA for an assessment of a technical nature (a technical assessment) before making an application, the APVMA may provide the technical assessment’.

A technical assessment involves the APVMA assessing data which may be used to support a future application for registration of a chemical product or a variation to relevant particulars of a registered product. Data may be submitted to determine its relevance to the safety, efficacy and trade criteria.

An outcome of an Item 25 can be used for a future application; however, the Agricultural Chemicals branch has noted an increase in lodged applications that rely on Item 25 outcome assessments that are not finalised and/or are being lodged before the Item 25 due date. We are unable to assess applications for registration or variations with a shorter timeframe than the Item 25 application or finalise applications that rely on a pending Item 25 outcome.

After you receive a supportive Item 25 assessment outcome and you wish to use it for a future application, please be reminded that you must lodge all the data that was assessed under the Item 25 as well as the assessment reports from the item 25 application.

More information on Item 25 assessments can be found at:

4.7. Bioequivalence Efficacy and Safety trials where the reference product has Limits on Use Information (LOUI)

The APVMA have received increased numbers of applications with Efficacy and Safety 3 assessments where bioequivalence trials are conducted to confirm equivalency between the efficacy and crop safety of a proposed and reference product while the reference product has relevant Efficacy and Safety Limits on Use of Information (LOUI) that has not yet expired. Please refer to the ‘Protected’ tab of the relevant reference product entry on the PubCRIS database to check for LOUI.

When determining the types of trials needed to demonstrate your product’s efficacy and crop safety in comparison to a reference product that has current Efficacy and Safety LOUI that is for the same use pattern you wish to apply for, please note the following:

  • Unless you have obtained written authorisation from the authorising party of the data, bioequivalence trials under an Efficacy and Safety 3 module are not appropriate.
  • If bioequivalence is not an available pathway, a more comprehensive data package for both efficacy and crop safety data will be required. Please refer to our guidance on Number of trials.
  • Applications that have bioequivalence trials for uses from a reference product with current relevant Efficacy and Safety LOUI, will likely result in a section 159 notice being issued, where the application can progress. You will be asked to submit written authorisation, provide equivalent efficacy and safety data or remove the use pattern from the draft label.
  • The APVMA may request you to amend the label to remove the protected uses under s11(4) or s28(4) of the Agvet Code.

Further guidance on bioequivalence trials can be found in Section 2.4 of the Pesticides Efficacy and Crop Safety General Guidelines (Part 8).

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