Potential regulatory options for ‘export only’ biologicals

Closed 22 Dec 2021

Opened 15 Nov 2021


The Therapeutic Goods Administration (TGA) is seeking feedback on potential options for the regulation of biological therapeutic goods (biologicals) manufactured in Australia for export only (and not for supply in Australia).

Biologicals are human tissue and cell-derived products and live animal cell, tissues or organs.

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 are seeking 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.

Consultation paper

This consultation paper outlines 2 options for a new pathway to allow biologicals for export only to be included in the ARTG, as well as a third option of maintaining the current regulatory requirements.

Potential regulatory options for 'export only' biologicals - Consultation paper

Making a submission

  1. Read the consultation paper about the proposed potential options for the regulation of export only biologicals (see link above).
  2. Go to the online consultation questions, complete and submit your response (see 'Give us your views' below).

Why your views matter

Therapeutic goods legislation does not currently provide a dedicated approval pathway for biologicals that are for ‘export only’, unlike for medicines and medical devices.

We are seeking your input on whether an export only pathway should be established for biologicals and, if so, in what form. We are seeking feedback to make sure:

  • the export only regulatory scheme for biologicals provides an appropriate pathway to minimise regulatory burden whilst ensuring that export only biologicals meet appropriate safety and quality standards
  • the standards applying to export only biologicals are suitable and fit for purpose
  • GMP requirements for export only biologicals are suitable
  • the biologicals framework aligns with how other therapeutic products are regulated by the TGA.

What happens next

We will review all feedback received in response to this consultation. Submissions received will be used to inform the Australian Government about which regulatory options should be supported.

Feedback will also be used to inform the relevant standards which are applicable to export only biologicals and the manufacturing requirements for these products.

There may be further consultations on the legislative options for export only biologicals which will help inform further details, including fees and charges.


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