TGA proposes changes to biologicals regulations

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Australia’s drug regulatory agency, the Therapeutic Goods Administration (TGA) announced on 20 April 2018 the release of proposed amendments to its biologicals regulations that are set to take effect on 1 July 2018.

Regulation V13H16

The proposed changes would regulate certain treatments that were previously excluded from the regulations. Under the proposal, a substance will be regulated as a biological rather than a blood component if it is subject to processing involving ‘more than minimal manipulation’. The broader definition incorporates conditioned serum and adipose-derived cell extract, which had previously been excluded from regulation.

Biologicals regulatory framework proposed changes
Date: 1 July 2018 

The regulation is similar to the European Medicines Agency’s approach for stem cell products and also mimics similar regulations in the US. This is not the first time that the TGA has aligned itself with regulations in Europe. In February 2014, the agency adopted EMA’s guideline on monoclonal antibodies [1].

The TGA says that the proposed changes to the regulatory framework are not yet law and that it welcomes feedback on this guidance at The agency will publish an updated version of the Australian Regulatory Guidelines for Biologicals (ARGB) in July 2018 when the changes to the Therapeutic Goods Regulations 1990 enter into force.

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1. GaBI Online - Generics and Biosimilars Initiative. Australia to adopt EMA’s monoclonal antibody guideline []. Mol, Belgium: Pro Pharma Communications International; [cited 2018 May 18]. Available from:

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Source: TGA

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