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Monday, May 23 • 09:15 - 10:15
Advancing the regulation of veterinary medicines in Australia

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This paper will discuss initiatives by the Australian Pesticides and Veterinary Medicines Authority (APVMA), the objective of which is to take a lighter touch regulatory approach to product registration. The initiatives will reduce the burden on industry in complying with regulatory requirements and be proportionate to the risks being managed while continuing to deliver regulatory decisions that are timely and science-based.
The revised regulatory approach to registration consists of the following four elements:
1) The introduction of a profiling tool that will determine the appropriate level of regulatory intervention for applications. Online self-assessment may be adequate for applications requiring less regulation whereas an expert assessment tailored to each product may be required for applications posing a higher risk to humans and/or target animals.
2) The assessment of applications for product registration will take into account relevant international data, assessments, standards, and decisions, in accordance with the guiding principles of the Government Competitiveness Agenda.
3) The development of chemical monographs, risk manuals, and standards for certain product types that pose a negligible or low risk. A standard, for example, may define the chemical composition of a formulation, the target animal species for the formulated product, product claims, and labelling under which the APVMA would be satisfied to register a product. The registration of those applications that comply with the relevant standard will be fast-tracked.
4) The trialing of contestability of efficacy assessments that transfer efficacy assessments from the APVMA to private sector providers. If the current pilot study demonstrates advantages to the APVMA and the applicant, further consultation will be conducted as to the contestability of future efficacy assessments.
When fully implemented, these initiatives will help to advance the regulation of veterinary medicines in Australia.

Speakers
avatar for Dr Philip Reeves

Dr Philip Reeves

Chief Regulatory Scientist, Australian Pesticides and Veterinary Medicines Authority
Dr Phil Reeves is the APVMA Chief Scientist. He is responsible for ensuring the APVMA’s regulatory science frameworks and standards continue to meet appropriate national and international standards. Through engagement with national and international scientific and regulatory networks... Read More →


Monday May 23, 2016 09:15 - 10:15
Room L2 Adelaide Convention Centre

Attendees (13)