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Veterinary remedies explained

10 March 2020

For Australian goat producers curious to know why they can’t access some of the animal health treatments producers that other countries such as South Africa can, understanding the regulatory process is key.

Veterinary remedies in Australia have to be registered by the national regulatory authority, the Australian Pesticides and Veterinary Medicines Authority (APVMA).

A complex situation

MLA Program Manager, Health Welfare & Biosecurity, Dr Johann Schröder, said it was important to understand the initiative for registering animal health treatments including drugs, chemicals or vaccines, does not come from the APVMA.

“The APVMA does not put a registered product on the market. The driver behind the whole process is the registrant – the commercial entity prepared to spend money on compiling the data package and submitting it to the regulator and, after registration, do the manufacture, warehousing, distribution, and after-sales service,” Dr Schröder said.

“This is a purely market-driven exercise, and only done if the market potential is persuasive.”

According to Dr Schröder, the market signals are complicated in the case of Australian goats. Although Australia is the largest exporter of goatmeat, exporting 90% of its production, most of this product comes from rangelands goats that need minimal treatment.

“Goats in managed herds that need treatment, such as drenching for internal parasites, present a very small market potential when compared with cattle and sheep,” he said.

The situation is further complicated by species differences. Although goats seem to be infested by many of the same parasites that plague cattle and sheep, they differ in the way they deal with chemicals and in most instances, require larger doses than for example, sheep.

“Because the market potential is too small, registrant companies won’t invest the money to generate the information needed to set accurate dosages, maximum residue limits (MRLs) and withholding periods (WHPs). As a result, there’s the risk of either under-dosing animals, leading to ineffective treatment and stimulating selection for resistance, or over-dosing, which poses the risk of violative residues in the meat of slaughtered goats.”

Different requirements for every country

Dr Schröder said every country with a formal registration process has its own set of registration requirements and the most sophisticated of these are considered to be the United States, the European Union and Japan.

“In Australia, veterinary remedies used to be registered on a state-by-state basis by the National Health and Medical Research Council (NH&MRC). The National Registration Authority (NRA), since renamed APVMA, was established more than 20 years ago to set this process on a more national footing,” Dr Schröder said.

“The information required by any national regulatory authority generally concerns the product quality (manufacturing facilities and processes; raw and finished material specifications), human and environmental safety, and target animal safety, toxicity and efficacy.

“There are overlaps in the requirements in different countries, such as in the areas of pre-clinical toxicity, done in laboratory animals, and subsequent residue depletion studies.

“These investigations give rise to the assessment which sets MRLs and WHPs in food animals. Although MRLs and WHPs might differ between countries, the toxicity and residue depletion studies usually don’t need to be repeated, due to an effort at international harmonisation of regulatory criteria.

“The differences lie in the clinical data (target/host animal) concerning efficacy, safety and toxicity. Some regulators insist on locally generated data, and local environmental impact data, to account for differences in geographical and climatic conditions, and pest species.

“If the APVMA considers overseas registration information in its decision making, they will more likely take their lead from sophisticated regulators, such as the US Food and Drug Administration, Japan, and the European Medicines Evaluation Agency, than from a country like South Africa.”