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How does Australian regulatory science compare with that of other countries?

30 June 2011

The Australian regulatory system is contemporary, uses the same frameworks and processes other national regulators use and is well regarded by its international peers.

This is demonstrated through:

  • common scientific study requirements and assessment processes
  • the type and quality of studies used in regulatory decision making
  • active involvement in international regulatory science fora
  • partnering with other national regulators to assess new active constituents
  • provision of expert advice to other regulatory agencies.

Common scientific study requirements and assessment processes

The APVMA has a very similar assessment framework to that used in comparable countries such as the United States of America, Canada, Europe and New Zealand. This is because each country/region has aligned their frameworks to those developed by international agencies such as the International Programme on Chemical Safety (IPCS) and the Organisation for Economic Cooperation and Development (OECD).

Most countries, for example, use assessment processes based on data requirements and assessment methods developed by IPCS. Similarly, many countries consistently use OECD test guidelines to determine how studies submitted to regulatory authorities are to be conducted. OECD guidance documents also provide guidance on how those studies should be assessed. The APVMA, for example, has adopted the OECD format for registration applications and is revising its Manual of Requirements and Guidelines to align with this format.

The type and quality of studies used in regulatory decision making

The APVMA relies on the same type and quality of studies as other regulators in making decisions about individual chemicals.

Regulators typically rely on information from scientific studies to make decisions. But not all studies are of the same type and quality. They vary in terms of reliability and relevance. At one end of the continuum are epidemiological studies that use statistical correlations to suggest risk factors. Many of these studies are speculative in nature and have known forms of bias and error. They are useful for identifying potential hazards or hypothesis generation, but they cannot determine cause and effect. Toward the other end are laboratory-based studies that demonstrate direct cause and effect relationships using real life contexts.

Studies that can be consistently replicated by other researchers and deliver the same results are highly valued. So too is the case when the scientific community develops a consensus around the causes of a particular condition.

Thus while the APVMA shares with other national regulators a caution about responding to epidemiological studies in isolation, we will always respond to experimental studies that demonstrate direct causal relationships capable of being replicated by other researchers. Cases where a scientific consensus exists are also highly valued.

Active involvement in international regulatory science fora

Australian regulatory processes reflect international best practice because of the active involvement of the APVMA and its advisory agencies in international regulatory activities.

The APVMA actively participates in many OECD, United Nations Food and Agriculture Organization (FAO) and WHO expert working groups and committees. It chairs a number of working groups and regularly contributes to the development of international guidance documents. In recent years, for example, the APVMA has helped develop a number of OECD guidance documents as well as guidelines on metabolism and residue kinetics for the trilateral (EU-Japan-USA) International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH).

Partnering with other national regulators to assess new active constituents

The Australian regulatory system is so well regarded by other national regulatory bodies that they wish to partner with the APVMA to assess new chemicals. Australia is an active participant in Global Joint Reviews. Under this process, regulatory authorities undertake assessments for new pesticide active constituents concurrently across the world. Each participating country undertakes to be the primary reviewer of one aspect of the assessment and a secondary reviewer for others. Each country accepts the assessments other countries make and one scientific monograph is produced that is used as a basis for the regulatory decisions in each country. Australia has participated in more than 15 of these reviews partnering with countries such as the United States, Canada, Germany, the United Kingdom, Brazil and New Zealand.

Provision of expert advice to other regulatory agencies

Many countries ask the APVMA to provide advice on how they might improve their regulatory systems. The APVMA receives regular requests for assistance of this nature and also regularly hosts staff from overseas regulators for training purposes.

If Australian regulatory science is so similar to that used by overseas regulators then why are there differences in the types of chemicals and products authorised in different countries?

Most countries share a common range of pesticides and veterinary medicines. The suite of chemicals authorised in one country or region may differ to that in another for a number of reasons including:

  • different climatic conditions and pest pressures
  • different market decisions made by chemical companies
  • differences in legislative criteria for chemical approval including special purpose authorisations.

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Last updated on 30 June, 2011