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Consultation on potential regulatory options for 'export only' biologicals

15 November 2021

Opening date: 15 November 2021

Closing date: 22 December 2021

The Therapeutic Goods Administration (TGA) conducted a public consultation on potential options for the regulation of biologicals manufactured in Australia for export only (and not for supply in Australia).

Currently, biologicals included in the Australian Register of Therapeutic Goods (ARTG) can be exported, but they are not permitted to vary from the product supplied in Australia. This means that 'export only' biologicals cannot have different indications, release specifications, or labels to the product approved by the TGA, even if the importing country has assessed and approved the product independently.

We sought feedback on:

  • potential options for the creation of a new regulatory pathway for export only biologicals
  • suitability of current standards and Good Manufacturing Practice (GMP) requirements for biologicals for export only goods.

For more information and to have your say, please view the consultation paper and complete the online survey on the TGA Consultation Hub.

The public consultation opened on 15 November 2021 and closed on 22 December 2021.

Enquiries

If you have questions relating to this consultation please email TGA.Scientific@health.gov.au.