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AgVetLink: Number 58, October 2006

Australia/New Zealand Alignment of Regulatory Control of Agricultural Compounds and Veterinary Medicines

NZFSA met with its counterparts in the Australian Pesticides and Veterinary Medicines Authority (APVMA) in Canberra last month to progress the alignment workplan.

Differing roles

Initially, a comparison of functions and range of products regulated seemed to pose a major challenge – the statutory mandates of APVMA and NZFSA, the range of products regulated, and the reasons why they are regulated appeared to be significantly different. However, on closer inspection it became clear that the perceived differences related more to differences in distribution of responsibilities within government agencies. In Australia APVMA has overall responsibility for registering agricultural and veterinary chemicals; the functions of assessing risks to the environment, public health, occupational health and safety, and providing advice to APVMA reside with other government agencies. In New Zealand other government agencies and independent authorities are responsible for issuing approvals and/or consents as prerequisites before NZFSA issues registrations for agricultural compounds or veterinary medicines. The net effect is the same.

More inclusive workplan

This insight led to the conclusion that, even though managing the risks in some areas are not specifically statutory mandates of both APVMA and NZFSA, alignment could best be achieved by broadening discussions and the workplan to cover the full mandate of both agencies and ensuring that the other government agencies and independent authorities are kept informed, consulted and asked to comment or even to participate in initiatives to achieve alignment. The workplan is being adjusted accordingly.

Achievements to date

Alignment of good manufacturing practices (GMP) has been achieved and cooperation between Australia and New Zealand is working well.

There has also been a comparison of functions related to regulatory control of agricultural and veterinary chemicals, highlighting where other government agencies and independent authorities play a part. This was followed by a comparison of product types to reach an understanding of the status quo, but both APVMA and NZFSA are reviewing the results and consulting with interested and affected parties. This is likely to lead to changes in the scope of regulatory control in both countries.

The agencies are also in the midst of a comparison of selected veterinary medicines that have recently been registered to identify commonalities in the assessment and registration process. This preliminary work will inform future alignment of standards and processes, and facilitate information sharing.

New Zealand

In New Zealand discussions on (and development of) the workplan have been shared with ERMA NZ, and work has begun to develop a process to ensure that alignment with Australia is productive and appropriate from the perspectives of both ERMA and NZFSA.

NZFSA also intends to discuss the alignment programme with the Ministry of Health, particularly MEDSAFE, to keep them informed and give them the opportunity to participate.