In September 2016, the Government announced that the TGA would introduce a list of permitted indications that must be used by listed medicine sponsors to enter their product indications in the ARTG. There will be no option when listing a product for free text. The purpose cited by the TGA of establishing the list of permitted indications is to:

  • ensure that listed medicines can only make low level indications that are suitable for medicines that do not undergo pre-market assessment
  • provide transparency for sponsors on what indications are suitable for listed medicines to help