Emerging Markets Regulatory Tracker: Australia (Vol. 4 No. 59)
This article was originally published in PharmAsia News
Executive Summary
Australia’s Therapeutic Goods Administration has issued amended non-clinical studies guidance needed to register a prescription medication.
The Emerging Markets Regulatory Tracker is prepared for PharmAsia News by RegLink Associates, which tracks regulatory, policy and health technology assessments around the world for biopharma and medical device executives.
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The previous issue of the Emerging Markets Regulatory Tracker appeared here: (Also see "Emerging Markets Regulatory Tracker: Australia (Vol. 4 No. 58)" - Scrip, 14 Sep, 2014.).
TGA Issues Amended Nonclinical Studies Guidance
Australia’s Therapeutic Goods Administration (TGA) issued amended nonclinical studies guidance on Sept. 15 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, 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.