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Animal health sector encouraged to develop international perspective

21 April 2010
Updated 22 April 2010

The Animal Health Alliance (AHA) (external site), the industry body representing veterinary pharmaceutical companies, recently asserted that the Australian Pesticides and Veterinary Medicines Authority is stifling innovation by being too slow in assessing, testing and approving new animal treatments for the Australian market.

It claimed that the APVMA is "incapable of taking into account reputable assessment data from similar regulatory agencies overseas". This, it argues, slows the process down unnecessarily. A sheep drench submitted for approval in a number of countries but yet to gain approval here was proposed as evidence.

In 2009 the APVMA wrote to its chemical industry stakeholders, including AHA members, specifically advising that the APVMA would accept international chemistry assessment reports. More than that, the APVMA has been encouraging major chemical companies to participate in joint international assessments – an exciting new development where a new product can be simultaneously assessed across multiple national jurisdictions.

This pathway creates significant efficiencies, promotes innovation and brings products to market sooner. It has been increasingly adopted by the crop protection sector, with the APVMA seeing a dramatic rise in applications for new active constituents from this sector over the last year or so. These new chemicals may present significant benefits to Australian growers.

For some years now the crop protection industry has taken a global approach to the way it brings new product to market. The industry shares its development and marketing plans with relevant regulators well ahead of submission and encourages interagency dialogue and cooperation.

The result is that these companies generate one package of information that they submit at about the same time to each international regulator. The agencies coordinate their assessments, share the work and produce a commonly agreed monograph that each country uses to undertake its risk assessment and make its decision.  The benefits are that the time taken to reach registration is nearly halved and new crop protection tools become available for producers at about the same time.  The OECD, for example, has just released an assessment detailing the large savings in time and money (external site) being generated. Not surprisingly, the APVMA has seen a surge in the number of new agricultural compounds under assessment.

The animal health industry in Australia has been slow to adopt this international approach. Applications for registration of the sheep drench in question were submitted individually in different national jurisdictions. If a coordinated international approach had been followed, Australian registration may have been achieved sooner. Nonetheless, the Australian application is progressing well and within statutory timeframes.

The APVMA looks forward to working with the animal health industry to think and plan globally, and encourages companies to share their plans for development with the APVMA and overseas agencies well ahead of submission time. This approach is not only efficient but also effective.

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