Regulatory Outline in Australia

The registration of a drug starts with an application in which the sponsor includes all data required by the NRA for evaluating new animal drugs. An outline of the required data includes  

Data to identify the active constituent, its chemical and physical properties, formulation composition, batch analysis and stability, process chemistry, analytical methods, and quality control 

Results of acute, short-term and long-term toxicity studies, reproduction studies, developmental studies, genotoxicity studies, and studies of the toxicity of metabolites and impurities, and other adverse effects. Data on human toxicology, the no observable effect level, acceptable daily intake, and proposed and safety directions 

Results of metabolic and toxicokinetic studies in laboratory and target animals 

Complete, detailed proposed use patterns for the product, including dose rate, regimen, and proposed withholding period data showing the nature, level and safety of residues and metabolites in livestock and poultry 

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