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  • Regulatory NewsRegulatory News

    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...
  • TGA Calls for Biologics Applications in Advance of Deadline

    Australia's Therapeutic Goods Administration (TGA) is reminding all biologics manufacturers that, per a new regulatory framework for biological medicines, that they must re-register their products with the Australian Register of Therapeutic Goods (ARTG) by 31 May 2014 or risk sanctions. The framework is intended to better regulate human tissue and cell-based therapies by classifying biological products based on risk, the agency has said. Under a new "special transitio...