Biologicals regulatory framework changes from 1 July 2018

Including changes to regulation of autologous human cell and tissue products and classification of biologicals

2 July 2018

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The Biologicals Regulatory Framework has been modified through changes to therapeutic goods regulations and legislative instruments following public consultation in 2015 and 2016.

These proposed changes are now law. This guidance represents TGA's interpretation of and intention for the recent changes to:

  • the regulation of autologous human cell and tissue products which could be regulated either:
    • under the Biological framework or
    • or as Medicine products as blood and blood components
  • biologicals classification and terminology definitions (associated with biologicals classification).

We will be publishing an updated version of the Australian Regulatory Guidelines for Biologicals (ARGB) soon.

This guidance has been developed by the TGA and therefore the use of 'we' and 'us' throughout refers to TGA.

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