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Pathways for supply of biologicals

Australian Regulatory Guidelines for Biologicals (ARGB)

27 July 2018

Not everything that meets our definition of a biological is regulated as a biological. Before reading this guidance, check that your product is regulated as a biological by reading:

If you are new to the regulatory environment, you may find the following information helpful:

Pathways for supply

The pathway for supply of biological products in Australia varies depending on whether your product is:

You should also familiarise yourself with the manufacturing principles that will apply to manufacturing sites relating to your product, and the sponsor has certain responsibilities related to GMP clearance and certification for these sites.

Exempt biologicals

Certain autologous human cell and tissue products may be eligible for exemption from some regulatory requirements, but you must:

  • meet specific eligibility criteria
  • fulfil some regulatory obligations

To understand if your product is eligible and what regulatory requirements you must still comply with, refer to Exempt autologous HCTs.

'Unapproved' biologicals

We encourage supply of biologicals that are on the ARTG because they have been evaluated for quality, safety and efficacy. However, if you need to supply a biological that is not on the ARTG (an 'unapproved' biological'), the following pathways are available, depending on whether the use is:

For more information see: Access to unapproved biologicals.

Biologicals included on the ARTG

If your biological is not otherwise exempt, approved or authorised, then you must apply to include your biological on the ARTG.

The process for inclusion on the ARTG is to:

  1. Classify your biological
  2. Apply to include your biological on the ARTG

Biologicals may also be packaged with or combined with another therapeutic good. These may be defined as either a combination product or a biological kit, composite pack or system/procedure pack.

Version history
Version Description of change Author Effective date
V1.0 Original publication incorporating new legislative changes and information previously published on the TGA website.

Biological Science Section

Regulatory Guidance Team

July 2018