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Regulatory Focus™ > News Articles > Australia Clarifies Transitional Requirements for Biologicals

Australia Clarifies Transitional Requirements for Biologicals

Posted 19 September 2012 | By Louise Zornoza

In May 2011 Australia's Therapeutic Goods Administration (TGA) put in place a Biologicals Regulatory Framework to assess and regulate human tissue-based products.  Until then, those products were either not regulated, regulated as drugs or devices, or exempt from certain parts of the Therapeutic Goods Act.

As part of the three year transition period, the TGA yesterday issued a notice to sponsors of biologicals that are currently supplied in Australia, but not currently included in the  Australian Register of Therapeutic Goods (ARTG). These sponsors, which include tissue banks supplying bone, ocular, cardiovascular and other biological products, have until 30 November 2012 to submit an application for registration or risk losing the right to market as of 31 May 2014. The notice specifies that products marketed before 31 May 2011 with applications submitted by the 2012 deadline can remain on the market after the 2014 cutoff even if a final decision has not been taken by the TGA on the application.

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