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Regulatory News
17 September 2014
by Louise Zornoza

Australia’s TGA Issues Amended Nonclinical Studies Guidance

This content is provided by RegLink News, publishers of e-weekly global regulatory news. RegLink offers a 30-day free trial and 15% discount on Global Update subscriptions to RAPS members.

 

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:

  • All relevant nonclinical information, whether favorable or unfavorable to the medicine
  • Details of any incomplete or abandoned pharmacological or toxicological testing, as well as individual animal data from toxicity studies, and
  • Additional pharmacodynamic and pharmacokinetic studies
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