Regulatory Focus™ > News Articles > TGA Calls for Biologics Applications in Advance of Deadline

TGA Calls for Biologics Applications in Advance of Deadline

Posted 15 October 2012 | By Alexander Gaffney, RAC 

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 transition arrangement," TGA said it is encouraging sponsors to submit their applications by 30 November 2012 to avoid being caught up in a three-year transition period. Products submitted after 30 November will be subject to the transition period, during which time TGA will be required to classify the product. Product submitted before will be allowed to remain on the market even if TGA does not make a decision during that time, the agency said.

TGA also said that donor screening tests are a priority under the new law. All sponsors must ensure that required infectious disease testing is conducted and conveyed to regulators. The requirements include details of testing, information on tests and methods, details of contracted testing and validation details about screening tests. Tests must also be assessed by TGA for suitability, accuracy and validity.


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