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Regulatory News | 17 September 2014 | By Louise Zornoza
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Australia’s Therapeutic Goods Administration (TGA) this week (15 September 2014) issued an amended guidance on nonclinical studies for Module 4 of the Common Technical Document (CTD), which is an integral part of an application to register a prescription medicine on the Australian Register of Therapeutic Goods (ARTG).
The amended guidance differs from the European Union (EU) guidelines for nonclinical studies, which have been adopted by Australia, by requiring additional information to be included in Module 4, including:
Tags: ARTG, TGA, Australia, Module 4, CTD